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

Gossamer Bio

Status and phase: Terminated; Phase 1

Conditions: Small-cell Lung Cancer; Urothelial Carcinoma; Castration-resistant Prostate Cancer; Pancreatic Adenocarcinoma; Microsatellite Stable Colorectal Cancer; Gastric Adenocarcinoma; Non-small Cell Lung Cancer; Hepatocellular Carcinoma; Esophageal Squamous Cell Carcinoma; Esophageal Adenocarcinoma; Renal Cell Carcinoma; Triple Negative Breast Cancer; Gastroesophageal Junction Adenocarcinoma; Head and Neck Squamous Cell Carcinoma

Treatments: Drug: pembrolizumab; Drug: nab-paclitaxel and gemcitabine; Drug: GB1275

Study type: Interventional

Funder types: Industry

Identifiers

NCT04060342

GB1275-1101 (KEYNOTE-A36)

Details and patient eligibility

About

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

Full description

Note: The Phase 2 portion of the study was not initiated.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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61 participants in 6 patient groups

Phase 1: Regimen A - GB1275 monotherapy

Experimental group

Description:

GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).

Treatment:

Drug: GB1275

Phase 1: Regimen B - GB1275 with an Anti-PD-1

Experimental group

Description:

GB1275 with pembrolizumab dose escalation and expansion: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).

Treatment:

Drug: GB1275

Drug: pembrolizumab

Phase 1: Regimen C - GB1275 with Standard of Care (SOC)

Experimental group

Description:

GB1275 with SOC dose escalation: GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI)

Treatment:

Drug: GB1275

Drug: nab-paclitaxel and gemcitabine

Phase 2: Cohort 1 - GB1275 with SOC

Experimental group

Description:

GB1275 with SOC Basket Cohort in patients with newly diagnosed metastatic pancreatic cancer: GB1275 oral administration; twice per day (BID) and nab-paclitaxel and gemcitabine per USPI.

Treatment:

Drug: GB1275

Drug: nab-paclitaxel and gemcitabine

Phase 2: Cohort 2 - GB1275 with an Anti-PD-1

Experimental group

Description:

GB1275 with pembrolizumab Basket Cohort in patients with MSS colorectal cancer: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).

Treatment:

Drug: GB1275

Drug: pembrolizumab

Phase 2: Cohort 3 - GB1275 with an Anti-PD-1

Experimental group

Description:

GB1275 with pembrolizumab Basket Cohort in patients with gastric/GEJ cancer, PD-L1 positive: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).

Treatment:

Drug: GB1275

Drug: pembrolizumab