Trial Profile

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)

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 07 Apr 2026

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At a glance

Drugs GI 101 (Primary) ; Lenvatinib (Primary) ; Pembrolizumab (Primary)
Indications Bladder cancer; Cervical cancer; Colorectal cancer; Non-small cell lung cancer; Renal cell carcinoma; Solid tumours; Urogenital cancer
Focus Adverse reactions; Therapeutic Use
Acronyms Keynote B59
Sponsors GI Innovation

17 Mar 2026 Protocol has been amended(Chnage in primary endpoints, planned patient numbers and addition of new indications).
17 Mar 2026 Planned number of patients changed from 430 to 317.
17 Mar 2026 Planned End Date changed from 1 Dec 2026 to 30 Jun 2028.

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