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Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

Study of the Glutaminase Inhibitor CB-839 in Solid Tumors

Many tumor cells, in contrast to normal cells, have been shown to require the amino acidglutamine to produce energy for growth and survival. To exploit the dependence of tumors onglutamine, CB-839, a potent and selective inhibitor of the first enzyme in glutamineutilization, glutaminase, will be tested in this Phase 1 study in patients with solidtumors.

This study is an open-label Phase 1 evaluation of CB-839 in patients with advanced solidtumors. The study will be conducted in 2 parts. Part 1 is a dose escalation study enrollingpatients with locally-advanced, metastatic and/or refractory solid tumors to receive CB-839capsules orally twice or three times daily.

In Part 2, patients with each of the following diseases will be enrolled: A) Triple-NegativeBreast Cancer, B) Non-Small Cell Lung Cancer (adenocarcinoma), C) Renal Cell Cancer, D)Mesothelioma, E) Fumarate hydratase (FH)-deficient tumors, F) Succinate dehydrogenase(SDH)-deficient gastrointestinal stromal tumors (GIST), G) SDH-deficient non-GIST tumors,and H) tumors harboring mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2.

As an extension of Part 2, patients with locally-advanced or metastatic TNBC will beenrolled to evaluate the safety and tolerability of standard dose paclitaxel and CB-839.

All patients will be assessed for safety, pharmacokinetics (plasma concentration of drug),pharmacodynamics (inhibition of glutaminase), biomarkers (biochemical markers that maypredict responsiveness in later studies), and tumor response.

Stanford is currently accepting patients for this trial. For more information, please contact Pei-Jen Chang at 650-725-0866 .

Lead Sponsor:

Calithera Biosciences, Inc

Stanford Investigator(s):

Intervention(s):

  • Drug: CB-839

Phase:

Phase 1

Eligibility


Inclusion criteria

   - Advanced malignancy that is relapsed and/or refractory to all available therapies
   that will confer clinical benefit. Newly diagnosed patients who refuse standard
   treatment regimens are also eligible

   - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

   - Life Expectancy of at least 3 months

   - Adequate hepatic, renal, cardiac, and hematologic function

   - Measurable disease by RECIST criteria

   - Ability to provide written informed consent in accordance with federal, local, and
   institutional guidelines

Exclusion Criteria

   - Any other current or previous malignancy

   - Chemotherapy, radiation therapy, hormonal therapy, immunotherapy or biological
   therapy, or investigational agent within 21 days

   - Unable to receive medications oral medications

   - Major surgery within 28 days before Cycle 1 Day 1

   - Active infection requiring within 2 weeks prior to first dose of study drug

   - Patients who have HIV, Hepatitis A, B or C or CMV reactivation

   - Significant neurotoxicity/neuropathy (Grade 3 or higher) within 14 days of first dose
   of study drug

   - Conditions that could interfere with treatment or protocol-related procedures

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Both

Now accepting new patients

Explore Related Trials

All Stanford Trials

Contact Information

Primary Contact:
Pei-Jen Chang
650-725-0866

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305