NCT06462183

Study of Safety and Efficacy of RGT-61159 in Adults With Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

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: Phase 1
• Study type: Interventional
• Enrollment: 105 (estimated)
• Sponsor: Rgenta Therapeutics Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 study to evaluate safety, tolerability and anti-tumor activity of RGT-61159 in patients with ACC or CRC

Detailed description

This first-in-human, Phase 1, multi-center, open-label, non-randomized study, is designed to evaluate safety, tolerability, and anti-tumor activity of once-daily RGT-61159 in patients with advanced R/R ACC or R/R CRC for whom standard therapy with proven clinical benefit does not exist, is no longer effective, or is not appropriate. RGT-61159 is an oral, small molecule MYB inhibitor.

Conditions

• Adenoid Cystic Carcinoma
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	RGT-61159	Oral MYB inhibitor

Timeline

• Start date: 2024-08-19
• Primary completion: 2025-12-01
• Completion: 2027-06-01
• First posted: 2024-06-17
• Last updated: 2025-11-14

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study