OncoMatch/Clinical Trials/NCT04977453
GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors
Is NCT04977453 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies multiple treatments including GI-101 and Pembrolizumab (KEYTRUDA®) for advanced solid tumor.
Treatment: GI-101 · Pembrolizumab (KEYTRUDA®) · Lenvatinib · GI-101A — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Other
Cancer type
Tumor Agnostic
Cervical Cancer
Urothelial Carcinoma
Renal Cell Carcinoma
Non-Small Cell Lung Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: immunotherapy related to mode of action of GI-101
Previous immunotherapies related to mode of action of GI-101.
Cannot have received: systemic anti-cancer therapy
Exception: excluding investigational agents within 4 weeks prior to treatment
Administration of prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to treatment.
Cannot have received: radiation therapy
Exception: limited field palliative radiotherapy
Radiotherapy within the last 2 weeks before start of study treatment administration, with exception of limited field palliative radiotherapy
Lab requirements
Blood counts
Has adequate organ and marrow function as defined in protocol.
Kidney function
Has adequate organ and marrow function as defined in protocol.
Liver function
Has adequate organ and marrow function as defined in protocol.
Has adequate organ and marrow function as defined in protocol.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Tisch Cancer Institute (TCI), Icahn School of Medicine · New York, New York
- Carolina Biooncology Institute · Huntersville, North Carolina
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT04977453 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy related to mode of action of GI-101, systemic anti-cancer therapy, radiation therapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages