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A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors

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Trial Profile

A Phase 1/2, Open-label, Multi-center Study of the Safety, Tolerability, and Efficacy of GIM-531 as a Single Agent and in Combination With Anti-PD-1 in Advanced Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Mar 2025

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At a glance

  • Drugs GIM 531 (Primary)
  • Indications Malignant melanoma; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Georgiamune

Most Recent Events

  • 22 Jan 2025 Planned number of patients changed from 84 to 117.
  • 30 Jul 2024 According to a Georgiamune media release, the first patient has been dosed from this study.
  • 29 May 2024 According to a Georgiamune media release, the company receives U.S. FDA clearance for Investigational New Drug (IND) application of GIM-531 to initiate a first-in-human clinical trial to investigate GIM-531.

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