NCT06118086

Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma

A Phase 1/2, Multicenter, Open-label Study of REM-422, a MYB mRNA Degrader, in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Remix Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine the safety and antitumor effects of REM-422, a MYB mRNA degrader, in people with advanced Adenoid Cystic Carcinoma (ACC)

Detailed description

This is a Phase 1/2, open-label, non-randomized, multicenter study investigating REM-422, a potent, selective, and oral small molecule mRNA degrader that reduces expression of the MYB transcription factor for patients with recurrent, metastatic, or unresectable ACC. This study includes a Dose Escalation Phase and a Confirmatory Cohort phase. The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of REM-422 in patients with recurrent or metastatic ACC. The purpose of the Confirmatory Cohort is to further evaluate the safety and anti-tumor activity of the RP2D carried forward from Dose Escalation in patients with recurrent, metastatic, or unresectable ACC. Participation in this study will continue until disease progression, therapy intolerance, or participant withdrawal.

Conditions

• Adenoid Cystic Carcinoma
• Metastatic Adenoid Cystic Carcinoma
• Recurrent Adenoid Cystic Carcinoma

Interventions

Type	Name	Description
DRUG	REM-422	* REM-422 is a first in class, small molecule mRNA inhibitor that reduces expression of the MYB transcription factor * REM-422 will be administered orally once daily

Timeline

• Start date: 2023-12-20
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2023-11-07
• Last updated: 2026-02-18

Locations

8 sites across 2 countries: United States, France

Regulatory

• FDA-regulated drug study