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

Part of paid clinical trials in San Francisco, California.

Sponsor
Remix Therapeutics
Study ID
NCT06118086
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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)

Key Dates

Start date
Dec 20, 2023
Status verified
Feb 2026
Primary completion
Jun 1, 2026
Completion
Jun 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: REM-422
    * Dose Escalation: Participants will receive escalating doses of REM-422 to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)-422, oral capsule administered once daily * Ph 2 Confirmatory Cohort: Participants will receive REM-422 at the identified RP2D * Treatment will continue until disease progression, therapy intolerance, or participant withdrawal * Safety evaluation will continue until 30 days of last administration of REM-422

Primary Outcome Measure

Frequency and severity of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 18 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San Francisco Helen Diller Comprehensive Cancer CenterSan FranciscoCalifornia94143
Hyunseok Kang, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer Research InstituteBostonMassachusetts02215
Glenn Hanna, MD (PRINCIPAL_INVESTIGATOR)
University of Michigan Rogel Cancer CenterAnn ArborMichigan48109
Paul L Swiecicki, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alan L Ho, MD, PhD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InstituteNashvilleTennessee37203
Meredith McKean, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Renata Ferrarotto, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Francisco, CA

By research site
University of California San Francisco Helen Diller Comprehensive Cancer Center· San Francisco, CADana Farber Cancer Research Institute· Boston, MAUniversity of Michigan Rogel Cancer Center· Ann Arbor, MIMemorial Sloan Kettering Cancer Center· New York, NYSarah Cannon Research Institute· Nashville, TNMD Anderson Cancer Center· Houston, TX

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