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
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
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 18, 2022 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
- Interventions being studied
- Drug: GB1275; Drug: nab-paclitaxel and gemcitabine; Drug: pembrolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- 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
- 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/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCSF Medical Center at Mission BaySan Francisco, California
- University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)Aurora, Colorado
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, Missouri
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Duke University Medical CenterDurham, North Carolina
- The Sarah Cannon Research Institute/Tennessee OncologyNashville, Tennessee
- South Texas Accelerated Research Therapeutics, LLCSan Antonio, Texas
- The Royals Marsden NHS Foundation TrustSutton, Surrey
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 18, 2022. Always confirm current availability with the study team.