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Study of GBR 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03983395
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Glenmark Pharmaceuticals S.A.

Brief Summary:
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent GBR 1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: GBR 1302 250 ng/kg Biological: GBR 1302 325 ng/kg Biological: GBR 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22 Biological: GBR 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22 Biological: GBR1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22 Biological: GBR1302 325ng/kg D1;550 ng/kg D8;900 ng/kg D15,22 Biological: GBR1302 escalating doses,1200 ng/kg D15,22 Biological: GBR1302 at the MTD and/or RP2D dose Phase 1 Phase 2

Detailed Description:
To determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent GBR 1302 in subjects with HER2-positive metastatic breast cancer who have been treated with all known therapies known to confer clinical benefit.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Dose-Escalation Study of GBR 1302 in Subjects With HER2-Positive Metastatic Breast Cancer
Estimated Study Start Date : June 22, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Part 1: Cohort 101 - GBR 1302 250 ng/kg
Cohort 101, subjects will be administered GBR 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 250 ng/kg
Biological: GBR 1302 250 ng/kg
GBR 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 250 ng/kg

Experimental: Part 1: Cohort 201 - GBR 1302 325 ng/kg
Cohort 201, subjects will be administered GBR 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 325 ng/kg
Biological: GBR 1302 325 ng/kg
GBR 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 325 ng/kg

Experimental: Part 1:Cohort 301-GBR 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22
Cohort 301, subjects will be administered GBR 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 425 ng/kg on D8, D15, D22
Biological: GBR 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22
GBR 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 425 ng/kg on D8, D15, D22

Experimental: Part 1:Cohort 401-GBR 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22
Cohort 401, subjects will be administered GBR 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, D15, D22
Biological: GBR 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22
GBR 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, D15, D22

Experimental: Part1Cohort501-GBR1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22
Cohort 501, subjects will be administered GBR 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 700 ng/kg on D15, D22
Biological: GBR1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22
GBR 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 700 ng/kg on D15, D22

Experimental: Part1Cohort601-GBR1302 325ng/kgD1;550 ng/kg D8;900 ng/kgD15,22
Cohort 601, subjects will be administered GBR 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 900 ng/kg on D15, D22
Biological: GBR1302 325ng/kg D1;550 ng/kg D8;900 ng/kg D15,22
GBR 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 900 ng/kg on D15, D22

Experimental: Part 1 Cohort 701- GBR 1302 escalating doses,1200 ng/kg D15,22
Cohort 701, subjects will be administered GBR 1302 by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 700 ng/kg on D8, and 1200 ng/kg on D15, D22
Biological: GBR1302 escalating doses,1200 ng/kg D15,22
GBR 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of GBR 1302 is 325 ng/kg on D1 and 700 ng/kg on D8, and 1200 ng/kg on D15, D22

Experimental: Part 2 (Dose Expansion) -GBR 1302 at the MTD and/or RP2D dose
Subjects treated with GBR 1302 at the MTD and/or RP2D dose in separate groups in the Q1W and/or the Q2W dose regimen.
Biological: GBR1302 at the MTD and/or RP2D dose
GBR 1302 at the MTD and/or RP2D dose in separate groups in the Q1W and/or the Q2W dose regimen.




Primary Outcome Measures :
  1. MTD: Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug (i.e. Cycle 1) in each cohort. [ Time Frame: 28 days ]
    MTD: Number of DLTs (dose limiting toxicities) during the first 28 days after the first administrations of study drug (i.e. Cycle 1) in each cohort.

  2. RP2D: Incidence and severity of AEs, AESI, and SAEs, including but not limited to laboratory values, PK and biomarkers. [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    RP2D: Incidence and severity of AEs, AESI, and SAEs, including but not limited to laboratory values, PK and biomarkers.

  3. Anti-tumor Activity of GBR 1302 administered Q1W (Part 2) [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Tumor Response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (Part 2)


Secondary Outcome Measures :
  1. Incidence, nature, and intensity of AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0. [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Incidence, nature, and intensity of AEs according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

  2. Antitumor activity of GBR 1302 administered Q1W (Part 1) [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Tumor Response per RECIST v1.1.

  3. Additional preliminary anti-tumor clinical activity of GBR 1302administered (Part 2) [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Tumor Response per RECIST v1.1

  4. Pharmacokinetics of GBR 1302 administered Q1W (Part 1 and Part 2) -Cmax [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    PK parameter: Cmax - maximum observed serum concentration is estimated

  5. Pharmacokinetics of GBR 1302 administered Q1W (Part 1 and Part 2)-tmax [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    PK parameter: tmax - time at which Cmax is observed

  6. Pharmacokinetics of GBR 1302 administered Q1W (Part 1 and Part 2) -AUC0-tau [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    PK parameter: AUC0-tau - Area under the serum concentration-time curve over a dosing interval is estimated.

  7. Pharmacokinetics of GBR 1302 administered Q1W (Part 1 and Part 2) - AUC0-t [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    PK parameter: AUC0-t - Area under the serum concentration-time curve over the time interval from zero to last quantifiable concentration is estimated.

  8. Immunogenicity of GBR 1302 administered Q1W (Part 1 and Part 2) [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Percent incidence of antidrug antibodies (ADA) formation assessed from baseline until end of treatment (EOT)

  9. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) - levels of pharmacodynamic cytokines- IL-2 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Levels of cytokines, including IL-2 will be measured in peripheral blood as part of the pharmacodynamics and safety assessment to monitor for any signs of cytokine release syndrome.

  10. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) - levels of pharmacodynamic cytokines- IL-6 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Levels of cytokines, including IL-6 will be measured in peripheral blood as part of the pharmacodynamics and safety assessment to monitor for any signs of cytokine release syndrome.

  11. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) - levels of pharmacodynamic cytokines- IL-10 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Levels of cytokines, including IL-10 will be measured in peripheral blood as part of the pharmacodynamics and safety assessment to monitor for any signs of cytokine release syndrome.

  12. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) - levels of pharmacodynamic cytokines- IFN-γ [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Levels of cytokines, including IFN-γ will be measured in peripheral blood as part of the pharmacodynamics and safety assessment to monitor for any signs of cytokine release syndrome.

  13. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) - levels of pharmacodynamic cytokines- TNF-α [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Levels of cytokines, including TNF-α, will be measured in peripheral blood as part of the pharmacodynamics and safety assessment to monitor for any signs of cytokine release syndrome.

  14. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Pharmacodynamic Cellular Biomarkers -CD3 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Cellular biomarkers to be analyzed include CD3 will be assessed by fluorescence activated cell sorting (FACS) analysis of peripheral blood leucocytes as surrogate markers for GBR 1302 activity

  15. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Pharmacodynamic Cellular Biomarkers -CD4 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Cellular biomarkers to be analyzed include CD4 will be assessed by fluorescence activated cell sorting (FACS) analysis of peripheral blood leucocytes as surrogate markers for GBR 1302 activity

  16. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Pharmacodynamic Cellular Biomarkers -CD8 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Cellular biomarkers to be analyzed include CD8 will be assessed by fluorescence activated cell sorting (FACS) analysis of peripheral blood leucocytes as surrogate markers for GBR 1302 activity

  17. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Pharmacodynamic Cellular Biomarkers -CD25 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Cellular biomarkers to be analyzed include CD25 will be assessed by fluorescence activated cell sorting (FACS) analysis of peripheral blood leucocytes as surrogate markers for GBR 1302 activity

  18. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Pharmacodynamic Cellular Biomarkers -CD69 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Cellular biomarkers to be analyzed include CD69 will be assessed by fluorescence activated cell sorting (FACS) analysis of peripheral blood leucocytes as surrogate markers for GBR 1302 activity

  19. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Pharmacodynamic Cellular Biomarkers - CD127 [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Cellular biomarkers to be analyzed include CD127 will be assessed by fluorescence activated cell sorting (FACS) analysis of peripheral blood leucocytes as surrogate markers for GBR 1302 activity

  20. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Tumor tissue biopsy -Analyses of the tumor tissue include T cells [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Descriptive statistics for pharmacodynamic biomarker assessments such as Tumor tissue biopsy - Analyses of the tumor tissue include T cells

  21. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Tumor tissue biopsy -Analyses of the tumor tissue include tumor microenvironment markers [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Descriptive statistics for pharmacodynamic biomarker assessments such as Tumor tissue biopsy - Analyses of the tumor tissue include tumor microenvironment markers

  22. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Tumor tissue biopsy -Analyses of the tumor tissue include apoptotic markers [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Descriptive statistics for pharmacodynamic biomarker assessments such as Tumor tissue biopsy - Analyses of the tumor tissue include apoptotic markers

  23. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Tumor tissue biopsy -Analyses of the tumor tissue include Tumor Mutational Burden (TMB) [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Descriptive statistics for pharmacodynamic biomarker assessments such as Tumor tissue biopsy - Analyses of the tumor tissue include Tumor Mutational Burden (TMB)

  24. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Tumor tissue biopsy -Analyses of the tumor tissue include Epigenetic evaluation of Tregs [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Descriptive statistics for pharmacodynamic biomarker assessments such as Tumor tissue biopsy - Analyses of the tumor tissue include Epigenetic evaluation of Tregs

  25. Exploratory: Pharmacodynamic biomarkers of GBR 1302 (Part 1 and Part 2) -Tumor tissue biopsy -Analyses of the tumor tissue include Epigenetic evaluation of T helper cells [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Descriptive statistics for pharmacodynamic biomarker assessments such as Tumor tissue biopsy - Analyses of the tumor tissue include Epigenetic evaluation of T helper cells

  26. Exploratory: Duration of treatment (Part 1 and Part 2) [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Tumor response per RECIST v1.1 and iRECIST

  27. Exploratory: Time to disease progression (Part 1 and Part 2) [ Time Frame: Treatment cycles of 28 days, treatment cycles may continue, if there is clinical benefit, until disease progression, unacceptable toxicity, withdrawal, or end of study or cycles may continue beyond disease progression, treatment cycles for up to 6 months ]
    Tumor Response per RECIST v1.1 and iRECIST



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females with HER2-positive (IHC 2+, with ISH confirmation) or 3+ (IHC or ISH) metastatic breast cancer which has been treated with all therapy known to confer benefit.
  • Measurable disease, defined as per RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG ) performance-status score of 2 or less
  • Adequate bone marrow, renal, and liver function.
  • Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug
  • Must be willing to undergo pre-treatment and on-treatment biopsies in Part 1 and Part 2.

Exclusion Criteria:

  • Any suspected or proven immunocompromised state, or infections, such as history of positive human immunodeficiency virus (HIV), known active or chronic hepatitis B virus (HBV) or hepatitis C virus (HCV).
  • Any history or evidence of clinically significant cardiovascular disease.
  • Evidence of clinically significant cardiovascular and respiratory conditions
  • Previous antineoplastic treatment with immune checkpoint regulator or comparable immunotherapy within 8 weeks of starting study drug.
  • Chemotherapy, radiotherapy, molecular-targeted therapy, or biological therapies (including HER2-directed therapies) within 4 weeks of starting study drug
  • Hormone therapy within 2 weeks of starting study medications.
  • Diagnosed with another malignancy that requires active therapy
  • Brain metastases that require directed therapy.
  • Has not recovered from any therapy related toxicities from previous treatments.
  • Use of any investigational drug within 4 weeks from the start of study drug.
  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03983395


Contacts
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Contact: Phumla Adesanya 201- 684 - 8000 clinicaltrialsdisclosuredesk@glenmarkpharma.com

Locations
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United States, Arizona
Glenmark Investigational Site 1 Not yet recruiting
Gilbert, Arizona, United States, 85234
Contact: Lida Mina, MD    480-256-6444    Lida.Mina@bannerhealth.com   
United States, Kentucky
Glenmark Investigational Site 4 Not yet recruiting
Louisville, Kentucky, United States, 40212
Contact: Elizabeth Riley, MD         
United States, Michigan
Glenmark Investigational Site 2 Not yet recruiting
Detroit, Michigan, United States, 48201
Contact: Amy Weise, DO         
United States, Pennsylvania
Glenmark Investigational Site 3 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Saveri Bhattacharya, MD         
Sponsors and Collaborators
Glenmark Pharmaceuticals S.A.
Investigators
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Study Director: Dr. Andrea Acocella, MD, MBA Glenmark Pharmaceutical S.A

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Responsible Party: Glenmark Pharmaceuticals S.A.
ClinicalTrials.gov Identifier: NCT03983395     History of Changes
Other Study ID Numbers: GBR 1302-103
IND Number 131316 ( Other Identifier: FDA )
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Glenmark Pharmaceuticals S.A.:
Breast Cancer
GBR 1302
HER2

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases