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A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)

NCT05824975

This study is recruiting at 5 US sites in 5 states, according to its ClinicalTrials.gov record last updated .

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-102 as a single agent and in combination with conventional anti-cancer drugs, pembrolizumab or trastuzumab deruxtecan(T-DXd) over a range of advanced and/or metastatic solid tumors.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Soft Tissue Sarcoma (STS)
  • Platinum-resistant Ovarian Cancer (PROC)
  • Hepatocellular Carcinoma (HCC)
  • Colorectal Cancer (CRC)
  • HER2 Negative Breast Cancer
  • Cutaneous Melanoma
  • Renal Cell Carcinoma (RCC)

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
GI Innovation, Inc.
Last updated on ClinicalTrials.gov
November 25, 2024

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arizona · 1

  • Mayo Clinic in Arizona · Scottsdale, AZ

Florida · 1

  • Mayo Clinic in Florida · Jacksonville, FL

Minnesota · 1

  • Mayo Clinic in Minnesota · Rochester, MN

New York · 1

  • Memorial Sloan-Kettering Cancer Center · New York, NY

Ohio · 1

  • Cleveland Clinic · Cleveland, OH

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.