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

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.