Study of REM-422 for Patients with Advanced Adenoid Cystic Carcinoma
Sponsor: Remix Therapeutics
ClinicalTrials ID:NCT06118086
This clinical trial is testing a new drug, REM-422, to see if it is safe and can help shrink tumors in people with advanced Adenoid Cystic Carcinoma (ACC).
Patient Parameters
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Program Overview
The purpose of this study is to find out if REM-422, a new oral medication, is safe and effective in treating people with advanced Adenoid Cystic Carcinoma (ACC). The study will be conducted in two phases: the first phase will determine the best dose of REM-422, and the second phase will further evaluate its safety and effectiveness in shrinking tumors.
Description
This study is open to adults with advanced Adenoid Cystic Carcinoma (ACC) that has come back, spread, or cannot be removed by surgery. The study will test a new drug called REM-422, which is taken by mouth and works by targeting a specific protein involved in cancer growth.
The study has two parts:
- Dose Escalation Phase: This part will find the highest dose of REM-422 that patients can tolerate without severe side effects.
- Confirmatory Cohort Phase: This part will further test the safety and effectiveness of the dose found in the first phase.
Participants will continue in the study until their cancer progresses, they experience intolerable side effects, or they choose to leave the study.
Eligibility Criteria
Inclusion Criteria
- Must be able to understand and agree to the study requirements.
- Must be 18 years or older.
- Must have a confirmed diagnosis of Adenoid Cystic Carcinoma (ACC).
- For the Dose Escalation Phase: Must have advanced or spreading ACC with signs of disease progression.
- For the Confirmatory Cohort Phase: Must have ACC that is spreading, has come back, or cannot be removed by surgery, with measurable disease.
- Must have a specific genetic marker in their tumor.
- Must be in good general health with a performance status of 0 or 1.
- Must provide a tumor sample for testing.
- Must have stopped previous cancer treatments at least 3 weeks before starting REM-422.
- Must have recovered from side effects of previous treatments.
- Must be able to swallow pills.
- Must have good oxygen levels in the blood.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
- Men must agree to use effective birth control and not donate sperm during the study.
- Must have adequate blood counts and organ function.
Exclusion Criteria
- Allergic to REM-422 or similar drugs.
- Have an active infection that requires treatment.
- Have active HIV, hepatitis B, or hepatitis C infections.
- Have a primary immune deficiency.
- Need daily high-dose steroids.
- Have received a live vaccine within 6 weeks before starting the study.
- Taking certain medications that affect REM-422.
- Pregnant or planning to become pregnant, or breastfeeding.
- Have digestive issues that affect medication absorption.
- Have significant heart disease.
- Have had major surgery within 4 weeks before starting the study.
- Have had an organ transplant requiring immune suppression.
- Have an autoimmune disease.
- Have had radiation therapy within 7 days before starting the study.
- Have another type of cancer within 2 years, except for certain skin or cervical cancers.
- Participating in another clinical trial within 3 weeks before starting the study.
- Unable or unwilling to follow study requirements.
- Any condition that might interfere with the study or safety evaluation.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of California San Francisco Helen Diller Comprehensive Cancer Center | 94143 | San Francisco | California |
| Dana Farber Cancer Research Institute | 02215 | Boston | Massachusetts |
| University of Michigan Rogel Cancer Center | 48109 | Ann Arbor | Michigan |
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| Sarah Cannon Research Institute | 37203 | Nashville | Tennessee |
| MD Anderson Cancer Center | 77030 | Houston | Texas |
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