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Adenoid Cystic CarcinomaPhase 1/2NCT06118086

Study of REM-422 in Patients With Recurrent, Metastatic, or Unresectable Adenoid Cystic Carcinoma

A Phase 1/2 study testing REM-422 in people with Adenoid Cystic Carcinoma and Metastatic Adenoid Cystic Carcinoma, run by Remix Therapeutics at 9 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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) Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
REM-422
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
9 sitesin 2 countries
Study dates
20 Dec 2023to 30 Sep 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.
  • 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.
  • 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 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.
  • 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.
  • 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, myalgia, alopecia, prior therapy-related endocrinopathies, etc.), and patients with these conditions may enroll.
  • 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. Women who have undergone surgical or ablative sterilization or who have been postmenopausal for ≥ 2 years are not considered to be of childbearing potential.
  • 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

Who cannot join

  • 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 enrollment are excluded (prophylactic antibiotics, antivirals or antifungals are permitted).
  • 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 the participant is on a stable dose.
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  • 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 or during the study
  • 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 malignancies including basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix.
  • 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.

Trial locations and contacts

9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Remix Therapeutics contact

781-827-0902

ClinicalTrials@remixtx.com

Rosalie Jiang contact

781-584-9390

rjiang@remixtx.com

9 sites in 2 countries

United States7 sites, 7 recruiting

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

    Paul L Swiecicki, MD

    Recruiting

  • Dana Farber Cancer Research Institute

    Boston, Massachusetts, 02215

    Glenn Hanna, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Renata Ferrarotto, MD

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

    Meredith McKean, MD

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Alan L Ho, MD, PhD

    Recruiting

  • University of California San Francisco Helen Diller Comprehensive Cancer Center

    San Francisco, California, 94143

    Alain Algazi, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Guilherme Rabinowits, MD

    Recruiting

Other trials in United States

France2 sites, 2 recruiting

  • Centre Antoine Lacassagne

    Nice, 06189

    Esma Saada-Bouzid, MD

    Recruiting

  • Institut de Cancerologie Gustave-Roussy

    Villejuif, 94805

    Caroline Even, MD

    Recruiting

Other trials in France

About this study

Official title: 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

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)

Read the detailed description

This is a Phase 1/2, open-label, non-randomized, multicenter study investigating REM-422, a potent, selective, and oral small molecule mRNA degrader that reduces expression of the MYB transcription factor for patients with recurrent, metastatic, or unresectable ACC.

This study includes a Dose Escalation Phase and a Confirmatory Cohort phase. The purpose of the Dose Escalation Phase is to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of REM-422 in patients with recurrent or metastatic ACC. The purpose of the Confirmatory Cohort is to further evaluate the safety and anti-tumor activity of the RP2D carried forward from Dose Escalation in patients with recurrent, metastatic, or unresectable ACC.

Participation in this study will continue until disease progression, therapy intolerance, or participant withdrawal.

Being tested
REM-422
Medical subject headings
Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REM-422Drug

    • REM-422 is a first in class, small molecule mRNA inhibitor that reduces expression of the MYB transcription factor
    • REM-422 will be administered orally once daily
Study groups in NCT06118086
Study groupRoleWhat they receive
REM-422Experimental* Dose Escalation: Participants will receive escalating doses of REM-422 to determine Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)-422, oral capsule administered once daily * Ph 2 Confirmatory Cohort: Participants will receive REM-422 at the identified RP2D * Treatment will continue until disease progression, therapy intolerance, or participant withdrawal * Safety evaluation will continue until 30 days of last administration of REM-422
Receives: Drug: REM-422

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency and severity of Treatment Emergent Adverse Events (TEAEs)

    Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and number of participants with Dose Limiting Toxicities will be assessed to determine Safety and Tolerability of REM-422

    Measured: 18 months

  2. Overall Response Rate (ORR) in Phase 2 Confirmatory Cohort

    ORR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422

    Measured: 18 months

  3. Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D)

    Frequency and severity of Treatment Emergent Adverse Events (TEAEs) will be evaluated according to the NCI-CTCAE version 5.0 and the number of participants with Dose Limiting Toxicities will be assessed

    Measured: Assessed at the end of Cycle 1 for each participant

Secondary outcomes (9)

  1. Median Progression Free Survival (mPFS)

    PFS will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422

    Measured: 6 months, 12 months

  2. Duration of Response (DoR)

    DoR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422

    Measured: 18 months

  3. Time to Response (mTTR)

    TTR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422

    Measured: 18 months

  4. Disease Control Rate (DCR)

    DCR will be evaluated using the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 following treatment with REM-422

    Measured: 6 months

  5. Median Overall Survival (mOS)

    mOS will be evaluated after treatment with REM-422

    Measured: 18 months

  6. Determine pharmacokinetic profile (Cmax) of REM-422

    Measure Maximal concentration (Cmax) of REM-422

    Measured: 18 months

  7. Determine pharmacokinetic profile (Cmin) of REM-422

    Measure Minimal concentration (Cmin) of REM-422

    Measured: 18 months

  8. Determine pharmacokinetic profile (Tmax) of REM-422

    Measure Time to peak drug concentration (Tmax) of REM-422

    Measured: 18 months

  9. Determine pharmacokinetic profile (AUC) of REM-422

    Measure Area Under the Curve (AUC) of REM-422

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start20 Dec 2023
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
125 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06118086
Sponsor's protocol ID
REM-422-101
Status last verified
Jun 2026
First submitted
13 Oct 2023
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing REM-422 in people with Adenoid Cystic Carcinoma and Metastatic Adenoid Cystic Carcinoma, run by Remix Therapeutics at 9 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Remix Therapeutics (781-827-0902, ClinicalTrials@remixtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency and severity of Treatment Emergent Adverse Events (TEAEs) (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06118086.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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