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GB1275 for Esophageal Cancer

Phase 1
Waitlist Available
Research Sponsored by GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, GB1275, on patients with metastatic pancreatic adenocarcinoma (cancer that has spread from the pancreas) or other specified metastatic solid tumors. The trial has two phases: 1) a dose escalation/expansion phase to test safety and effectiveness, and 2) a basket expansion phase to test effectiveness in different types of tumors.

Eligible Conditions
  • Esophageal Cancer
  • Colorectal Cancer
  • Small Cell Lung Cancer
  • Stomach Cancer
  • Breast Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Liver Cancer
  • Gastroesophageal Junction Adenocarcinoma
  • Prostate Cancer
  • Bladder Cancer
  • Non-Small Cell Lung Cancer
  • Kidney Cancer
  • Pancreatic Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 Dose Escalation - Regimens A and B: AUC of GB1275
Phase 1 Dose Escalation - Regimens A and B: CL/F of GB1275
Phase 1 Dose Escalation - Regimens A and B: Cmax of GB1275
+6 more
Secondary outcome measures
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: AUC of GB1275
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: CL/F of GB1275
Phase 1 - Regimen C and Phase 1 Expansion - Regimen B: Cmax of GB1275
+14 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 2: Cohort 3 - GB1275 with an Anti-PD-1Experimental Treatment2 Interventions
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).
Group II: Phase 2: Cohort 2 - GB1275 with an Anti-PD-1Experimental Treatment2 Interventions
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).
Group III: Phase 2: Cohort 1 - GB1275 with SOCExperimental Treatment2 Interventions
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.
Group IV: Phase 1: Regimen C - GB1275 with Standard of Care (SOC)Experimental Treatment2 Interventions
GB1275 with SOC dose escalation: GB1275 oral administration; twice per day (BID), and nab-paclitaxel and gemcitabine per United States Prescribing Information (USPI)
Group V: Phase 1: Regimen B - GB1275 with an Anti-PD-1Experimental Treatment2 Interventions
GB1275 with pembrolizumab dose escalation and expansion: GB1275 oral administration; twice per day (BID), and pembrolizumab IV administration once every 3 weeks (Q3W).
Group VI: Phase 1: Regimen A - GB1275 monotherapyExperimental Treatment1 Intervention
GB1275 Monotherapy dose escalation: Oral administration. Twice per day (BID).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pembrolizumab
2018
Completed Phase 3
~6240
nab-paclitaxel and gemcitabine
2016
Completed Phase 2
~330

Find a Location

Who is running the clinical trial?

GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.Lead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,868 Previous Clinical Trials
5,051,974 Total Patients Enrolled

Frequently Asked Questions

~11 spots leftby Mar 2025