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MYB mRNA degrader

REM-422 for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Remix Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have locally advanced or metastatic ACC.

Histologically confirmed ACC, any site of origin.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

Study Summary

This trial will test if a new drug, REM-422, is safe and effective for treating advanced ACC.

Who is the study for?

Adults with advanced Adenoid Cystic Carcinoma (ACC) who can consent, swallow pills, and have proper organ function. They must not have had recent non-study cancer treatments or major surgeries and should show disease progression. Women of childbearing age must test negative for pregnancy and agree to contraception.Check my eligibility

What is being tested?

The study tests REM-422's safety and effectiveness against ACC tumors. Participants will take this MYB mRNA degrader orally, with the trial having two phases: dose escalation for those showing symptoms or stable disease on intolerable treatment, and dose expansion for measurable progressing disease.See study design

What are the potential side effects?

Specific side effects of REM-422 are not listed but may include typical reactions to oral medications targeting tumor cells such as nausea, fatigue, possible allergic reactions, or changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is advanced or has spread to other parts of my body.

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My cancer, originating from any body part, is confirmed by tissue analysis.

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I am 18 years old or older.

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I can swallow and keep down pills.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My oxygen level is above 92% without needing much extra oxygen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and severity of Treatment Emergent Adverse Events (TEAEs)

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

Secondary outcome measures

Determine pharmacokinetic profile (AUC) of REM-422

Determine pharmacokinetic profile (Cmax) of REM-422

Determine pharmacokinetic profile (Cmin) of REM-422

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: REM-422Experimental Treatment1 Intervention

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 Dose Expansion: 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

0 / 6Eligibility criteria met

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Who is running the clinical trial?

Remix TherapeuticsLead Sponsor

1 Previous Clinical Trials

100 Total Patients Enrolled

Christopher Bowden, MDStudy ChairRemix Therapeutics

1 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has REM-422 been given the green light by the FDA?

"The safety of REM-422 is currently estimated to be a 1, as there is only minimal evidence available from Phase 1 trials on its efficacy and safety."

Answered by AI

Are recruitment efforts ongoing for this experiment?

"Clinicaltrials.gov indicates that this clinical trial is not presently seeking participants, despite having last been edited on November 1st 2023 and initially posted on the 15th of November 2023. Fortunately, there are 3388 other studies actively recruiting patients at present."

Answered by AI

What is the current scope of this trial's implementation across medical facilities?

"This research is being conducted in a total of 6 medical facilities, which are based out of Boston, Ann Arbor and New york City among other places. It may be practical to pick the closest clinic if you decide to participate, so as to reduce your travel requirements."

Answered by AI

What aims are researchers hoping to achieve by conducting this analysis?

"Remix Therapeutics, the clinical trial sponsor for this project, is primarily measuring Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) over an 18-month period. Secondary objectives include Median Progression Free Survival (mPFS), Duration of Response (DoR), and Time to Response (mTTR), all assessed according to RECIST version 1.1 criteria following treatment with REM-422."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Study of REM-422 in Patients With Recurrent or Metastatic Adenoid Cystic Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06118086.

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