Trial Profile

A Phase 1/2, Open-label, Dose-escalation, and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Therapeutic Activity of GI-101 as a Single Agent and in Combination With Pembrolizumab, Lenvatinib or Local Radiotherapy in Patients With Advanced or Metastatic Solid Tumors (Keynote B59)

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 03 Oct 2025

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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; Solid tumours
Focus Adverse reactions; Therapeutic Use
Acronyms Keynote B59
Sponsors GI Innovation

04 Sep 2025 Planned End Date changed from 1 Oct 2026 to 1 Dec 2026.
04 Sep 2025 Planned primary completion date changed from 1 Oct 2025 to 1 Oct 2026.
24 Oct 2023 Results(n=57) presented at the 48th European Society for Medical Oncology Congress

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