A Phase 1, Multicenter, Open-Label Study of REM-422, an MYB mRNA Degrader, in Patients With Relapsed/Refractory AML or Higher-Risk MDS

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 Higher Risk MDS and relapsed/refractory AML

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 higher risk MDS or relapsed/refractory AML. 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 higher risk MDS or relapsed/refractory AML. The purpose of Dose Expansion is to further evaluate the safe…

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Be able to provide informed consent. 2. Be 18 or older at the time of informed consent. 3. Disease criteria: Histologically confirmed diagnosis of either: 1. R/R AML, defined as relapse after transplantation, second or later relapse, refractory to initial induction or reinduction treatment or to initial treatment with hypomethylating (HMA)-based combinations, relapse after initial treatment, or otherwise considered relapsed or refractory in the opinion of the Investigator. 2. High-risk and very-high-risk (VHR) MDS (higher-risk) per the International Prognostic…

Interventions

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

Locations (9)

City of Hope
Duarte, California
Moffitt Cancer Center
Tampa, Florida
Massachusetts General Hospital
Boston, Massachusetts
Memorial Sloan Kettering
New York, New York
MD Anderson Cancer Center
Houston, Texas
Centre Hospitalier Universitaire (CHU) de Bordeaux
Bordeaux