Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma
Trial Parameters
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)
Eligibility Criteria
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 Cohort phase ONLY: * Have metastatic, recurrent, or unresectable ACC * Measurable disease at the time of enrollment. At least 1 measurable lesion according to RECIST v1.1 criteria. Participants must have radiographic evidence of disease progression by RECIST v1.1 criteria ≤ 6 months prior to study enrollment. Radiographic eligibility as determined by Central IUO assay. * MYB poison exon biomarker positive tumor(s) confirmed