Status:
TERMINATED
GB1275 Monotherapy and in Combination With an Anti-PD1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma
Lead Sponsor:
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Pancreatic Adenocarcinoma
Esophageal Adenocarcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation/Expansion phase of GB1275 monotherapy or in combination with Anti-PD-1 Antibody or in co...
Detailed Description
Note: The Phase 2 portion of the study was not initiated.
Eligibility Criteria
Inclusion
- Subject has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Women of childbearing potential must use an acceptable method of contraception
- Phase 1
- Subjects with the the following:
- Regimen A and B:
- pancreatic adenocarcinoma,
- esophageal adenocarcinoma, or esophageal squamous cell carcinoma, or
- gastric/gastroesophageal junction adenocarcinoma, or
- TNBC, or
- prostate cancer, or
- colorectal adenocarcinoma, or subjects with tumor types that have progressed after receiving initial treatment benefit rom the last single agent checkpoint inhibitor that is approved for the indication or in combination with standard of care therapy, for example, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell carcinoma, urothelial carcinoma, renal cell carcinoma, and hepatocellular carcinoma, etc.
- Regimen C: newly diagnosed stage IV pancreatic cancer
- Phase 2
- Cohort 1: pancreatic cancer.
- Cohort 2: colorectal cancer
- Cohort 3: gastric/GEJ adenocarcinoma
Exclusion
- History of another malignancy within 2 years prior to first study drug(s) administration, unless the malignancy was treated with curative intent and the likelihood of relapse is \<5% in 2 years
- Pregnant or nursing
- Known history of testing positive for human immunodeficiency virus (HIV)
- Gastrointestinal (GI) tract disease causing the inability to take oral medication.
- Positive test for Hepatitis B virus surface antigen (HBsAg) or a and/or positive Hep C antibody result with detectable hepatitis C virus (HCV) ribonucleic acid (RNA) indicating acute or chronic infection.
- Other protocol-defined inclusion/exclusion criteria will apply
Key Trial Info
Start Date :
August 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT04060342
Start Date
August 13 2019
End Date
April 11 2022
Last Update
August 18 2022
Active Locations (8)
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1
UCSF Medical Center at Mission Bay
San Francisco, California, United States, 94158
2
University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
Aurora, Colorado, United States, 80045
3
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, United States, 63110
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065