Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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

Official Title

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

Keywords

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 GEJ adenocarcinoma TNBC MSS mCRC PD-L1 + gastric cancer PD-L1 positive gastric cancer NSCLC SCLC newly diagnosed stage IV pancreatic adenocarcinoma HCC RCC HNSCC Transitional Cell Carcinoma Carcinoma Lung Neoplasms Carcinoma, Squamous Cell Adenocarcinoma Small Cell Lung Carcinoma Triple Negative Breast Neoplasms Squamous Cell Carcinoma of Head and Neck Gemcitabine Paclitaxel Pembrolizumab nab-paclitaxel and gemcitabine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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:

Phase 2

  • Cohort 1: pancreatic cancer.
  • Cohort 2: colorectal cancer
  • Cohort 3: gastric/GEJ adenocarcinoma

You CAN'T join if...

  • 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

Locations

  • UCSF Medical Center at Mission Bay
    San Francisco California 94158 United States
  • University of Colorado Hospital, Anschutz Cancer Pavilion (ACP)
    Aurora Colorado 80045 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GB006, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
ID
NCT04060342
Phase
Phase 1/2 Research Study
Study Type
Interventional
Participants
Expecting 242 study participants
Last Updated