Clinical Trial

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)

Recruiting Phase 1/2
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Record status
This record was last updated November 25, 2024 (before its estimated November 12, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-04-20; most recent amendment 2024-11-21.
Trial Details
NCT Number NCT05824975
Lead Sponsor GI Innovation, Inc.
Collaborators: Merck Sharp & Dohme LLC
Conditions 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 +1 more
Enrollment 358 participants
Start Date 2023-05-30
Primary Completion 2025-11-12 (estimated)
Study Completion 2027-04-24 (estimated)
Updated on ClinicalTrials.gov 2024-11-25