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Study identifier: NCT04977453 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: Advanced Solid Tumor · Metastatic Solid Tumor · Cervical Cancer  ·  Sponsor: GI Innovation, Inc.

PhasePhase 1/Phase 2
Planned participants317
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Recruiting sites have contact information. Please contact the sites directly.  ·  +8224042003  ·  clinical@gi-innovation.com

Always discuss trial participation with your own doctor first.

Locations (12)

Tisch Cancer Institute (TCI), Icahn School of MedicineNew York, New York, United StatesRecruiting
Carolina Biooncology InstituteHuntersville, North Carolina, United StatesRecruiting
The Catholic University of Korea Seoul ST.MARY'S HospitalSeoul, Banpo-daero, South KoreaRecruiting
Seoul National University Bundang HospitalSeoul, Bundang-gu, South KoreaRecruiting
Chungnam National University HospitalDaejeon, Daejeon, South KoreaRecruiting
Samsung Medical CenterSeoul, Gangnam, South KoreaRecruiting
The Catholic University of Korea St. Vincent's HospitalSuwon, Kyeonggi-do, South KoreaRecruiting
Korea University Anam HospitalSeoul, Seongbuk-gu, South KoreaRecruiting
Ewha Womans University Mokdong HospitalSeoul, Yangcheon-gu, South KoreaRecruiting
Yonsei University Health System, Severance HospitalSeoul, South KoreaRecruiting
Yonsei University Health System, Severance HospitalSeoul, South KoreaRecruiting
Asan Medical CenterSeoul, South KoreaRecruiting

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Source record: clinicaltrials.gov/study/NCT04977453