drugset
drugset / Trial / NCT04060342

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 ↗

Phase 1 Terminated 61 enrolled Gossamer Bio, Inc. Merck Sharp & Dohme LLC · collab
Non-randomizedSequentialOpen-labelTreatment

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

Timeline

Start
2019-08-13
Primary completion
2022-04-11
Completion
2022-04-11

Outcome

Outcome not reported

Stopped: “No clear benefit of GB1275 was observed either as monotherapy or in combination with pembrolizumab.”

Drugs

EvaluationDrugModalityDoseRoute
Subject GB1275 Unknown — Oral
Subject Pembrolizumab Monoclonal antibody — Intravenous
Background Gemcitabine Small molecule — Intravenous
Background Nab-paclitaxel Small molecule — Intravenous

Indications

castration-resistant prostate carcinoma colorectal cancer esophageal adenocarcinoma esophageal squamous cell carcinoma gastric adenocarcinoma gastroesophageal junction adenocarcinoma head and neck squamous cell carcinoma hepatocellular carcinoma non-small cell lung carcinoma pancreatic adenocarcinoma renal cell carcinoma small cell lung carcinoma triple-negative breast carcinoma urothelial carcinoma