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
NCT04060342 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61
Last updated 2022-08-18
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
Conditions
- Pancreatic Adenocarcinoma
- Esophageal Adenocarcinoma
- Esophageal Squamous Cell Carcinoma
- Gastric Adenocarcinoma
- Gastroesophageal Junction Adenocarcinoma
- Triple Negative Breast Cancer
- Castration-resistant Prostate Cancer
- Microsatellite Stable Colorectal Cancer
- Non-small Cell Lung Cancer
- Small-cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Urothelial Carcinoma
- Renal Cell Carcinoma
- Hepatocellular Carcinoma
Interventions
- DRUG
-
GB1275
Oral
- DRUG
-
nab-paclitaxel and gemcitabine
IV infusion
- DRUG
-
IV infusion
Sponsors & Collaborators
- collaborator INDUSTRY
-
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-13
- Primary Completion
- 2022-04-11
- Completion
- 2022-04-11
- FDA Drug
- Yes
Countries
- United States
- United Kingdom
Study Locations
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