Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma (NCT06118086) | Clinical Trial Compass
RecruitingPhase 1/2
Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma
United States100 participantsStarted 2023-12-20
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be able to provide informed consent.
✓. Be 18 years or older at the time of informed consent.
✓. Disease criteria:
✓. Histologically confirmed ACC, any site of origin.
✓. Dose Escalation phase ONLY:
✓. Confirmatory Cohort phase ONLY:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Tumor Tissue Requirements
Exclusion criteria
✕. 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.
✕. Primary immunodeficiency.
What they're measuring
1
Frequency and severity of Treatment Emergent Adverse Events (TEAEs)
Timeframe: 18 months
2
Overall Response Rate (ORR) in Phase 2 Confirmatory Cohort
Timeframe: 18 months
3
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)
Timeframe: Assessed at the end of Cycle 1 for each participant
. Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent. Topical or inhaled corticosteroids with minimal systemic absorption may enroll and continue minimal corticosteroids if the participant is on a stable dose.
✕. Live vaccine ≤ 6 weeks prior to the start of REM-422.
✕. Use of strong CYP3A inhibitors or CYP3A inducers