Actively Recruiting
Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma
Led by Remix Therapeutics · Updated on 2026-02-18
100
Participants Needed
8
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent
- 18 years or older at time of consent
- Histologically confirmed Adenoid Cystic Carcinoma (ACC)
- Dose Escalation Phase: Locally advanced or metastatic ACC with radiographic progression or disease symptoms
- Confirmatory Cohort Phase: Metastatic, recurrent, or unresectable ACC with at least one measurable lesion and biomarker positive tumor
- ECOG performance status 0 or 1
- Able to provide tumor tissue samples for biomarker testing
- At least 3 weeks since prior systemic non-investigational therapy
- Stable or recovered to Grade 1 toxicity from prior therapy
- Able to swallow and retain oral medications
- Oxygen saturation greater than 92% on room air or up to 2 L/min supplemental oxygen with Grade 1 or less dyspnea
- Negative pregnancy test for participants of childbearing potential
- Agree to use effective contraception if of childbearing potential
- Men agree to use contraception and avoid sperm donation during and 6 months after treatment
- Adequate bone marrow, organ function, and laboratory values
You will not qualify if you...
- Known allergy or contraindication to REM-422 or related drugs
- Active significant infection requiring intravenous antibiotics
- Active HIV, hepatitis B or C infection
- Primary immunodeficiency
- Need for daily systemic corticosteroids of 10 mg prednisone equivalent or more
- Live vaccine within 6 weeks before treatment
- Use of strong CYP3A inhibitors or inducers
- Use of drugs reducing stomach acid within 7 days before or during treatment
- Pregnant or breastfeeding
- Malabsorption syndrome or significant gastrointestinal disease
- Use of prohibited medications within 1 week before treatment
- Significant cardiovascular disease
- Major surgery within 4 weeks prior to enrollment
- History of organ transplant requiring immunosuppression
- History or current autoimmune disease
- Radiation therapy within 7 days before treatment
- Other malignancy within 2 years except certain treated cancers
- Receiving other investigational treatments within 3 weeks before enrollment
- Unwilling or unable to follow protocol requirements
- Any condition interfering with evaluation or safety interpretation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 8 locations
1
University of California San Francisco Helen Diller Comprehensive Cancer Center
San Francisco, California, United States, 94143
Actively Recruiting
2
Dana Farber Cancer Research Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
5
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
7
Centre Antoine Lacassagne
Nice, France, 06189
Not Yet Recruiting
8
Institut de Cancerologie Gustave-Roussy
Villejuif, France, 94805
Not Yet Recruiting
Research Team
R
Remix Therapeutics
CONTACT
R
Rosalie Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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