RECRUITING

Study of REM-422 in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma

Conditions

Adenoid Cystic Carcinoma Metastatic Adenoid Cystic Carcinoma Recurrent Adenoid Cystic Carcinoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Phase 1, Multicenter, Open-label Study of REM-422, a MYB MRNA Degrader, in Patients with Recurrent or Metastatic Adenoid Cystic Carcinoma

Quick Facts

Study Start:2023-12-20

Study Completion:2026-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06118086

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be able to provide informed consent. 2. Be 18 or older at the time of informed consent. 3. Disease criteria: * Histologically confirmed ACC, any site of origin. * Have locally advanced or metastatic ACC. * Dose Escalation phase ONLY: 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. * Dose Expansion phase ONLY: 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. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. 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 months or longer if there has been no systemic interval therapy since the last biopsy. A formalin-fixed paraffin-embedded block can be submitted or a minimum of 15 freshly 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	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.

Inclusion Criteria

Exclusion Criteria

1. Be able to provide informed consent.
2. Be 18 or older at the time of informed consent.
3. Disease criteria:
* Histologically confirmed ACC, any site of origin.
* Have locally advanced or metastatic ACC.
* Dose Escalation phase ONLY: 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.
* Dose Expansion phase ONLY: 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.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
5. 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 months or longer if there has been no systemic interval therapy since the last biopsy. A formalin-fixed paraffin-embedded block can be submitted or a minimum of 15 freshly 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

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.

Contacts and Locations

Study Contact

Remix Therapeutics

CONTACT

781-827-0902

ClinicalTrials@remixtx.com

Rosalie Jiang

CONTACT

781-584-9390

rjiang@remixtx.com

Principal Investigator

Christopher Bowden, MD

STUDY_CHAIR

Remix Therapeutics

Study Locations (Sites)

University of California San Francisco Helen Diller Comprehensive Cancer Center

San Francisco, California, 94143

United States

Dana Farber Cancer Research Institute

Boston, Massachusetts, 02215

United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

United States

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Remix Therapeutics

Christopher Bowden, MD, STUDY_CHAIR, Remix Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-20

Study Completion Date2026-06-01

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

Adenoid Cystic Carcinoma
Metastatic Adenoid Cystic Carcinoma
Recurrent Adenoid Cystic Carcinoma