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

NCT04977453

This study is recruiting at 3 US sites in 2 states, according to its ClinicalTrials.gov record last updated .

Summary

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Advanced Solid Tumor
  • Metastatic Solid Tumor
  • Cervical Cancer
  • Urothelial Carcinoma
  • Clear Cell Renal Cell Cancer (ccRCC)
  • Squamous Cell Non Small Cell Lung Cancer

Eligibility basics and study details

Study type
Interventional
Phase
Phase 1/2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
GI Innovation, Inc.
Last updated on ClinicalTrials.gov
September 14, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

New York · 2

  • Columbia University · New York, NY
  • Tisch Cancer Institute (TCI), Icahn School of Medicine · New York, NY

North Carolina · 1

  • Carolina Biooncology Institute · Huntersville, NC

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.