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Study of REM-422 for Adenoid Cystic Carcinoma

This study is testing a new oral medication called REM-422 for people with adenoid cystic carcinoma (ACC) that has come back, spread, or cannot be removed by surgery. REM-422 works by reducing a protein called MYB. The main goals are to see how safe REM-422 is, what dose works best, and how well it shrinks tumors. You may be able to join if you are 18 or older and have ACC that is advanced or has spread, with signs of progression. The study is currently recruiting participants.

Study design
This is an open-label, non-randomized study, meaning everyone knows what treatment is being given. It aims to enroll 125 participants and includes two phases: a dose escalation phase and a confirmatory phase.
What's involved
Participation continues until your disease gets worse, you can't tolerate the treatment, or you choose to stop.
Compensation
Not stated in the trial record.
Follow-up
The frequency and severity of side effects and how well the treatment works will be measured for 18 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06118086

Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma

Recruiting
PHASE1Ages 18+InterventionalTreatment
Remix Therapeutics
~125 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:REM-422

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency and severity of Treatment Emergent Adverse Events (TEAEs)
Measured over 18 months
+2 more outcomes measured

Conditions

Adenoid Cystic Carcinoma
Metastatic Adenoid Cystic Carcinoma
Recurrent Adenoid Cystic Carcinoma

Explore related trials

Adenoid Cystic CarcinomaMYB Gene

Where it's being run

9 sites across 8 states
France2
California1
Florida1
Massachusetts1
Michigan1
New York1
Tennessee1
Texas1

Study leadership

  • Mythili Koneru, MD, PhD · STUDY_CHAIR · Remix Therapeutics

Who to contact

Remix Therapeutics
[email protected]
781-827-0902
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 by central IUO assay. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Tumor Tissue Requirements

What this trial measures

  • Frequency and severity of Treatment Emergent Adverse Events (TEAEs)18 months

    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 Cohort18 months

    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)Assessed at the end of Cycle 1 for each participant

    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