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New treatment option for Adenoid Cystic Carcinoma
Official title Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma
ClinicalTrials.gov ID: NCT06118086
What this study is testing
What is REM-422?
REM-422 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for adenoid cystic carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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)
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be able to provide informed consent.
- Be 18 years or older at the time of informed consent.
- Disease criteria:
- Histologically confirmed ACC, any site of origin.
- Dose Escalation phase ONLY:
You likely can't join if
- Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.
- Clinically significant active infection. Simple urinary tract infection, uncomplicated bacterial pharyngitis responding to active treatment are...
- Evidence of active HIV infection.
- Evidence of currently active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Primary immunodeficiency.
- Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent. Topical or inhaled corticosteroids with minimal...
See the full eligibility criteria
- Be able to provide informed consent.
- Be 18 years or older at the time of informed consent.
- Disease criteria:
- Histologically confirmed ACC, any site of origin.
- Dose Escalation phase ONLY:
- 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...
- 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...
- MYB poison exon biomarker positive tumor(s) confirmed by central IUO assay.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Tumor Tissue Requirements
- Dose Escalation Phase ONLY: be able to provide during Screening a tissue specimen of either a fresh biopsy of a non-target lesion or an archival tumor sample obtained within the last 6 years. A formalin-fixed...
- Confirmatory Cohort phase ONLY: be able to provide, during Pre-Screening, a tissue specimen of either a fresh biopsy of non-targetable lesion or an archival tumor sample obtained within the last 6 years that is...
- At least 3 weeks since prior systemic non-investigational therapy at the time of start of REM- 422.
- Toxicities from prior therapy must be stable or recovered to ≤ Grade 1. Note: Stable chronic and clinically non-significant conditions (≤ Grade 2) that are not expected to resolve are exceptions (eg, neuropathy...
- Participants must be able to swallow and retain oral medications.
- Oxygen saturation \> 92% on room air or up to 2 L/min supplemental oxygen by nasal cannula with ≤ Grade 1 dyspnea.
- Participants of childbearing potential (POCBP) must have a negative serum beta-human chorionic gonadotropin test result.
- Participants Of Child Bearing Potential must agree to use acceptable, effective methods of contraception as outlined in Appendix 1 and not donate ova from Screening until 6 months after discontinuation of REM- 422...
- Men must agree to use acceptable, effective methods of contraception and must agree not to donate sperm from the start of receiving REM-422 until 6 months after discontinuation of REM-422.
- Adequate bone marrow, organ function and laboratory parameters
- Known hypersensitivity or contraindication to any component of REM-422 or to drugs chemically related to REM-422 or its excipients.
- Clinically significant active infection. Simple urinary tract infection, uncomplicated bacterial pharyngitis responding to active treatment are permitted. Participants receiving intravenous antibiotics ≤ 7 days prior to...
- Evidence of active HIV infection.
- Evidence of currently active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Primary immunodeficiency.
- Current or expected need for daily systemic corticosteroid therapy ≥ 10 mg of prednisone equivalent. Topical or inhaled corticosteroids with minimal systemic absorption may enroll and continue minimal corticosteroids if...
- Live vaccine ≤ 6 weeks prior to the start of REM-422.
- Use of strong CYP3A inhibitors or CYP3A inducers
- Drugs that reduce gastric acidity, such as H2-receptor antagonists (eg, ranitidine, famotidine) and proton pump inhibitors (e.g., omeprazole, esomeprazole) within 7 days prior to the initiation of REM-422 administration...
- Pregnancy or participants planning to become pregnant during the duration of the study, or lactation.
- Participants with malabsorption syndrome, a disease significantly affecting gastrointestinal function, or resection of the stomach or bowel.
- Current use of prohibited medication ≤ 1 week before starting REM-422.
- Clinically significant cardiovascular disease:
- Participants who have undergone major surgery (opening a mesenchymal barrier such as the pleural cavity, peritoneum, meninges, or surgical procedures requiring general anesthesia) \< 4 weeks prior to enrollment.
- History of organ transplant that requires use of immunosuppressive agents.
- History or current autoimmune disease (eg, Crohn's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus).
- Radiation therapy ≤ 7 days prior to the start of REM-422.
- Concurrent or previous other malignancy (other than adenoid cystic carcinoma, hematologic malignancies, or primary central nervous system [CNS] malignancies) ≤ 2 years of enrollment, except curatively treated...
- Participants receiving any other investigational treatment for any indication ≤ 3 weeks prior to enrollment.
- Unwillingness or inability to follow protocol requirements.
- Any condition that, in the opinion of the Investigator, would interfere with evaluation of REM-422 or interpretation of the participant's safety or study results.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Tampa, Florida, United States
- Boston, Massachusetts, United States
- Ann Arbor, Michigan, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Nice, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Tampa, Florida, United States; Boston, Massachusetts, United States; Ann Arbor, Michigan, United States; New York, New York, United States; Nashville, Tennessee, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.