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
Remix Therapeutics
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)
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 saf…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Be able to provide informed consent. 2. Be 18 years or older at the time of informed consent. 3. Disease criteria: 1. Histologically confirmed ACC, any site of origin. 2. Dose Escalation phase ONLY: * Have locally advanced or metastatic ACC * Evidence of radiographic progression and/or signs and symptoms associated with their disease (eg, pain, dyspnea, reduced performance status). Participants who have stable disease while being treated with another agent that is not tolerated are eligible after the appropriate washout period. 3. Confirmatory Coh…
Interventions
- DrugREM-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
Locations (8)
- University of California San Francisco Helen Diller Comprehensive Cancer CenterSan Francisco, California
- Dana Farber Cancer Research InstituteBoston, Massachusetts
- University of Michigan Rogel Cancer CenterAnn Arbor, Michigan
- Memorial Sloan Kettering Cancer CenterNew York, New York
- Sarah Cannon Research InstituteNashville, Tennessee
- MD Anderson Cancer CenterHouston, Texas