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)
Be able to provide informed consent.
Be 18 years or older at the time of informed consent.
Histologically confirmed ACC, any site of origin.
Have locally advanced or metastatic ACC
Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.
Clinically significant active infection. Simple urinary tract infection, uncomplicated bacterial pharyngitis responding to active treatment are permitted. Participants receiving intravenous antibiotics ≤ 7 days prior to enrollment are excluded (prophylactic antibiotics, antivirals or antifungals are permitted).
Evidence of active HIV infection.
Evidence of currently active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
Single group
REM-422
Drug* 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
Frequency and severity of Treatment Emergent Adverse Events (TEAEs)
Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and number of participants with Dose Limiting Toxicities will be assessed to determine Safety and Tolerability of REM-422
Overall Response Rate (ORR) in Phase 2 Confirmatory Cohort
ORR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)
Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and the number of participants with Dose Limiting Toxicities will be assessed
Median Progression Free Survival (mPFS)
PFS will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422
Duration of Response (DoR)
DoR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422
Time to Response (mTTR)
TTR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422
Disease Control Rate (DCR)
DCR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422
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