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)

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.

Trial Details

NCT ID
NCT05824975
Phase
PHASE1 / PHASE2
Sponsor
GI Innovation, Inc.
Status
RECRUITING
Cancer Type
Melanoma
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Jacksonville, Florida, United States|30.33218,-81.65565
  • Rochester, Minnesota, United States|44.02163,-92.4699
  • New York, New York, United States|40.71427,-74.00597
  • Cleveland, Ohio, United States|41.4995,-81.69541

Key Eligibility Criteria

  • Males and females aged ≥ 18 years (or ≥ 19 years according to local regulatory guidelines) at the time of screening.
  • Has adequate organ and marrow function as defined in protocol.
  • Measurable disease as per RECIST v1.1.
  • ECOG performance status 0-1.

For full eligibility, visit ClinicalTrials.gov.

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