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 now · Phase 1/Phase 2
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)
In brief
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.
Key facts
- Study ID
- NCT05824975
- Run by
- GI Innovation, Inc.
- People needed
- 358
- Starts
- 2023-05-30
- Expected to finish
- 2027-04-24
- Last updated by the study team
- 2024-11-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic in Arizona — Scottsdale, Arizona, United States (enrolling)
- Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)
- Mayo Clinic in Minnesota — Rochester, Minnesota, United States (enrolling)
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States (enrolling)
- Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
- Seoul National University Hospital — Seoul, Seoul, South Korea (enrolling)
- St. Vincent's Hospital — Suwon, suwon, South Korea (enrolling)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (enrolling)
- Yonsei University Health System, Severance Hospital — Seoul, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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