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: 27 Sep 2024

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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

24 Oct 2023 Results(n=57) presented at the 48th European Society for Medical Oncology Congress
26 Sep 2023 Number of arms changed from 4 to 6. Experimental arm GI-101A and GI-101A + Pembrolizumab added to study protocol.
26 Sep 2023 Planned number of patients changed from 374 to 430.

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