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Brief Title: 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

INTRODUCTION

  • Org Study ID: GB1275-1101 (KEYNOTE-A36)
  • Secondary ID: N/A
  • NTC ID: NCT04060342
  • Sponsor: GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

BRIEF SUMMARY

This first-in-human (FIH ) study is an open-label, multicenter study that consists of a Phase 1 Dose Escalation 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

  • Overall Status
    Recruiting
  • Start Date
    August 13, 2019
  • Phase
    Phase 1, Phase 2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Phase 1 - Regimens A, B,and C: Incidence of dose limiting toxicities (DLTs)

Primary Outcome 1 - Timeframe: Regimen A and B dose escalation Days 1-21, Regimen C dose escalations Days 1-36 days

Primary Outcome 2 - Measure: Phase 1 - Regimens A, B,and C: Incidence of adverse events (AEs)

Primary Outcome 2 - Timeframe: Regimen A, B, and C dose escalation from baseline through 30 days last dose

Primary Outcome 3 - Measure: Phase 1 - Regimens A and B: Cmax of GB1275

Primary Outcome 3 - Timeframe: From baseline through 30 days last dose

Primary Outcome 4 - Measure: Phase 1 - Regimens A and B: Ctrough of GB1275

Primary Outcome 4 - Timeframe: From baseline through 30 days last dose

Primary Outcome 5 - Measure: Phase 1 - Regimens A and B: Tmax of GB1275

Primary Outcome 5 - Timeframe: From baseline through 30 days last dose

Primary Outcome 6 - Measure: Phase 1 - Regimens A and B: t1/2 of GB1275

Primary Outcome 6 - Timeframe: From baseline through 30 days last dose

Primary Outcome 7 - Measure: Phase 1 - Regimens A and B: AUC of GB1275

Primary Outcome 7 - Timeframe: From baseline through 30 days last dose

Primary Outcome 8 - Measure: Phase 1 - Regimens A and B: CL/F of GB1275

Primary Outcome 8 - Timeframe: From baseline through 30 days last dose

Primary Outcome 9 - Measure: Phase 2 - Basket Cohorts 1, 2 and 3: Objective Response Rate (ORR)

Primary Outcome 9 - Timeframe: 24 months

CONDITION

  • 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

ELIGIBILITY

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: N/A

Role: N/A

Affiliation: N/A

Overall Contact

Name: N/A

Phone: 1-866-668-4083

Email: ClinicalTrials@gossamerbio.com

LOCATION

Facility Status Contact
Facility: University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
Aurora, Colorado 80045
United States
Status: Recruiting Contact: N/A
Facility: Washington University School of Medicine - Siteman Cancer Center
Saint Louis, Missouri 63110
United States
Status: Recruiting Contact: N/A
Facility: Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Status: Recruiting Contact: N/A
Facility: Duke University Medical Center
Durham, North Carolina 27710
United States
Status: Recruiting Contact: N/A
Facility: The Sarah Cannon Research Institute/Tennessee Oncology
Nashville, Tennessee 37203
United States
Status: Recruiting Contact: N/A
Facility: South Texas Accelerated Research Therapeutics, LLC
San Antonio, Texas 78229
United States
Status: Recruiting Contact: N/A
Facility: The Royals Marsden NHS Foundation Trust
Sutton, Surrey SM2 5PT
United Kingdom
Status: Recruiting Contact: N/A