Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
REM-422 in Advanced Adenoid Cystic Carcinoma
NCT06118086Phase 2
Key facts
- Status
- Recruiting
- Start
- Dec 2023
- Primary completion
- Sep 2027
- Countries
- 2
- Sponsor
- Remix Therapeutics
- Modality
- Small Molecules
- Drugs
- REM-422
- Conditions
- adenoid cystic carcinoma (ACC)
01
Overview
Phase 2, open-label, single-arm trial of REM-422 in adenoid cystic carcinoma (ACC), sponsored by Remix Therapeutics. Primary endpoints: Treatment Emergent Adverse Events at 18 months, Overall Response Rate at 18 months and 1 more. Started Dec 2023; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
REM-422
Participants receive REM-422 orally once daily. Dose Escalation phase determines MTD/RP2D; Confirmatory Cohort phase treats at RP2D.
03
Who it enrols
Adults with recurrent, metastatic, or unresectable Adenoid Cystic Carcinoma with ECOG 0-1, adequate organ function, and disease progression. Confirmatory cohort requires MYB poison exon biomarker positivity.
04
Endpoints
Primary
Treatment Emergent Adverse Events
Overall Response Rate
Maximum Tolerated Dose and/or Recommended Phase 2 Dose
Secondary
Median Progression Free Survival
Duration of Response
Median Time to Response
Disease Control Rate
Median Overall Survival
Maximum Plasma Concentration
Minimum Plasma Concentration
Time to Maximum Plasma Concentration
Beyond the preview
Go deeper on NCT06118086.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT06118086.