Trial Profile

A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 17 Nov 2025

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At a glance

17 Sep 2025 According to a Rgenta Therapeutics media release, U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to RGT-61159 for the treatment of adenoid cystic carcinoma (ACC).
08 Oct 2024 According to a Rgenta Therapeutics media release, the company announced that the first patients have been dosed in the Phase 1a/b clinical trial of RGT-61159.
16 Aug 2024 Planned initiation date changed from 1 Jun 2024 to 1 Aug 2024.

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