Informations générales (source: ClinicalTrials.gov)
A Phase 1/2, Multicenter, Open-label Study of REM-422, a MYB mRNA Degrader, in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma
Interventional
Phase 1/Phase 2
Remix Therapeutics (Voir sur ClinicalTrials)
décembre 2023
septembre 2027
26 juin 2026
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)
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Caroline EVEN | 03/07/2026 13:35:04 | Contacter | ||
Critères
Tous
1. Be able to provide informed consent.
2. Be 18 years or older at the time of informed consent.
3. Disease criteria:
1. Histologically confirmed ACC, any site of origin.
2. 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 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
1. 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 paraffin-embedded
(FFPE) block can be submitted or a minimum of 15 freshly sectioned unstained
slides. Agree to an on-treatment biopsy to be obtained ~4-8 weeks after
initiation of REM-422 unless medically contraindicated.
2. 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 interpretable
for the biomarker positivity. An FFPE block can be submitted or a minimum of 15
fresh sectioned unstained slides.
6. At least 3 weeks since prior systemic non-investigational therapy at the time of
start of REM- 422.
7. 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, myalgia, alopecia, prior therapy-related
endocrinopathies, etc.), and patients with these conditions may enroll.
8. Participants must be able to swallow and retain oral medications.
9. Oxygen saturation > 92% on room air or up to 2 L/min supplemental oxygen by nasal
cannula with ≤ Grade 1 dyspnea.
10. Participants of childbearing potential (POCBP) must have a negative serum beta-human
chorionic gonadotropin test result.
11. 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. Women who have undergone surgical
or ablative sterilization or who have been postmenopausal for ≥ 2 years are not
considered to be of childbearing potential.
12. 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.
13. Adequate bone marrow, organ function and laboratory parameters
Exclusion Criteria:
1. Known hypersensitivity or contraindication to any component of REM-422 or to drugs
chemically related to REM-422 or its excipients.
2. 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 enrollment are
excluded (prophylactic antibiotics, antivirals or antifungals are permitted).
3. Evidence of active HIV infection.
4. Evidence of currently active hepatitis B virus (HBV) or hepatitis C virus (HCV)
infection.
5. Primary immunodeficiency.
6. 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 the participant is on
a stable dose.
7. Live vaccine ≤ 6 weeks prior to the start of REM-422.
8. Use of strong CYP3A inhibitors or CYP3A inducers
9. 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 or during the study
10. Pregnancy or participants planning to become pregnant during the duration of the
study, or lactation.
11. Participants with malabsorption syndrome, a disease significantly affecting
gastrointestinal function, or resection of the stomach or bowel.
12. Current use of prohibited medication ≤ 1 week before starting REM-422.
13. Clinically significant cardiovascular disease:
14. 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.
15. History of organ transplant that requires use of immunosuppressive agents.
16. History or current autoimmune disease (eg, Crohn's disease, ulcerative colitis,
rheumatoid arthritis, systemic lupus).
17. Radiation therapy ≤ 7 days prior to the start of REM-422.
18. 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 malignancies including basal or
squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in situ of
the cervix.
19. Participants receiving any other investigational treatment for any indication ≤ 3
weeks prior to enrollment.
20. Unwillingness or inability to follow protocol requirements.
21. 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.