Brief Title
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
Official Title
A Phase 1/2, First-in-Human, Open-label, Dose Escalation Study of GB1275 Monotherapy and in Combination With an Anti-PD-1 Antibody in Patients With Specified Advanced Solid Tumors or in Combination With Standard of Care in Patients With Metastatic Pancreatic Adenocarcinoma, Followed by Basket Expansion of GB1275 With Standard of Care or in Combination With an Anti-PD-1 Antibody in Patients With Specified Metastatic Solid Tumors
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 combination with Standard of Care in Patients with Metastatic Pancreatic
Adenocarcinoma followed by a Phase 2 Basket Expansion phase in Patients with Specified
Metastatic Solid Tumors
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Phase 1 Dose Escalation - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)
Secondary Outcome
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275
Condition
Pancreatic Adenocarcinoma
Intervention
GB1275
Study Arms / Comparison Groups
Phase 1: Regimen A - GB1275 monotherapy
Description: GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
242
Start Date
August 13, 2019
Completion Date
March 2023
Primary Completion Date
March 2023
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT04060342
Organization ID
GB1275-1101 (KEYNOTE-A36)
Responsible Party
Sponsor
Study Sponsor
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Collaborators
Merck Sharp & Dohme LLC
Study Sponsor
, ,
Verification Date
February 2022