Spots Global Cancer Trial Database for Study of REM-422 in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

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Trial Identification

Brief Title: Study of REM-422 in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma

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

Study ID: NCT06118086

Conditions

Adenoid Cystic Carcinoma

Metastatic Adenoid Cystic Carcinoma

Recurrent Adenoid Cystic Carcinoma

Interventions

REM-422

Study Description

Brief 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, 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 or metastatic ACC. This study includes a Dose Escalation Phase and a Dose Expansion 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 Dose Expansion is to further evaluate the safety and anti-tumor activity of the RP2D carried forward from Dose Escalation. Participation in this study will continue until disease progression, therapy intolerance, or participant withdrawal.