GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and therapeutic activity of GI-101/GI-101A as a single agent or in combination with pembrolizumab or lenvatinib over a range of advanced and/or metastatic solid tumors.

Trial Details

NCT ID
NCT04977453
Phase
PHASE1 / PHASE2
Sponsor
GI Innovation, Inc.
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • GI-101
  • Pembrolizumab (KEYTRUDA®)
  • Lenvatinib
  • GI-101A
Locations (sample)
  • New York, New York, United States|40.71427,-74.00597
  • Huntersville, North Carolina, United States|35.41069,-80.84285
  • Seoul, Banpo-daero, South Korea|37.566,126.9784
  • Seoul, Bundang-gu, South Korea|37.566,126.9784
  • Daejeon, Daejeon, South Korea|36.34913,127.38493

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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