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

Source: https://onco.cc/trials/nct04977453/  
OnCo record `nct04977453` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Pembrolizumab, Lenvatinib in cervical cancer and non-small-cell lung cancer, run by GI Innovation, Inc., now recruiting.

## Summary

GI-101/GI-101A as a Single Agent or in Combination With Pembrolizumab or Lenvatinib in Advanced Solid Tumors is a phase 1/2 interventional study registered as NCT04977453 by GI Innovation, Inc., with 317 participants planned, started 2021-08-02 and due to reach its primary completion in 2028-06-30. Interventions recorded: GI-101, Pembrolizumab (KEYTRUDA®), Lenvatinib, GI-101A. Conditions listed: Advanced Solid Tumor, Metastatic Solid Tumor, Cervical Cancer, Urothelial Carcinoma. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT04977453
- Phase: 1/2
- Setting: A Phase 1/2, Open-label, Dose-escalation, Dose-optimization and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101/GI-101A as a Single Agent and in Combination With Pembrolizumab or Lenvatinib in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)
- Sponsor: GI Innovation, Inc.
- Enrolled: 317

## Sources

- ClinicalTrials.gov NCT04977453: https://clinicaltrials.gov/study/NCT04977453

## Connected records

- cancers: [Cervical cancer](https://onco.cc/cancers/cervical/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- drugs: [Lenvatinib](https://onco.cc/drugs/lenvatinib/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)

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