Trials / Terminated
TerminatedNCT04060342
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
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
Note: The Phase 2 portion of the study was not initiated.
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
| Type | Name | Description |
|---|---|---|
| DRUG | GB1275 | Oral |
| DRUG | nab-paclitaxel and gemcitabine | IV infusion |
| DRUG | pembrolizumab | IV infusion |
Timeline
- Start date
- 2019-08-13
- Primary completion
- 2022-04-11
- Completion
- 2022-04-11
- First posted
- 2019-08-19
- Last updated
- 2022-08-18
Locations
8 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04060342. Inclusion in this directory is not an endorsement.