What side effects are associated with this type of intervention?

Common treatments for Adenoid Cystic Carcinoma (ACC) include surgery, radiation therapy, and chemotherapy. Surgery and radiation therapy can cause side effects such as pain, swelling, and damage to surrounding tissues. Chemotherapy side effects often include nausea, vomiting, hair loss, and increased risk of infection. Targeted therapies, like MYB mRNA degraders, may cause side effects such as fatigue, gastrointestinal issues, and potential liver toxicity. It is important to discuss specific side effects with a healthcare provider, as they can vary based on the individual and the treatment regimen.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Adenoid Cystic Carcinoma (ACC) that target MYB mRNA degradation, similar to the investigational drug REM-422. Current treatments for ACC often involve surgery, radiation, and in some cases, chemotherapy. Molecularly targeted therapies and investigational approaches, such as farnesyltransferase inhibitors and other agents, are being explored but have not yet received FDA approval for ACC.

What other types of research exist?

Promising novel alternatives to REM-422 for Adenoid Cystic Carcinoma patients include SGI-1776, a Pim kinase inhibitor, which has shown potential in reducing Pim-1 expression in salivary gland tumors, and the NOTCH inhibitor AL101, which is currently being evaluated in a phase II trial for ACC. Additionally, c-kit TKIs like imatinib and dasatinib, although with minimal activity, and everolimus, an mTOR inhibitor, have been investigated for ACC.

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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.

Must not have

Participants with malabsorption syndrome, a disease significantly affecting gastrointestinal function, or resection of the stomach or bowel.

History of organ transplant that requires use of immunosuppressive agents.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing REM-422, an oral medicine, in people with advanced Adenoid Cystic Carcinoma (ACC) that has returned or spread. REM-422 aims to reduce a protein needed for cancer growth by breaking down its mRNA. The study will determine the best dose and evaluate its safety and effectiveness.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my stomach or intestines absorb food.

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I have had an organ transplant and take drugs to suppress my immune system.

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I have or had an autoimmune disease like Crohn's or lupus.

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I am not allergic to REM-422 or similar drugs.

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I am not taking strong CYP3A inhibitors or inducers.

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I have a serious heart condition.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency and severity of Treatment Emergent Adverse Events (TEAEs)

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

Secondary study objectives

Determine pharmacokinetic profile (AUC) of REM-422

Determine pharmacokinetic profile (Cmax) of REM-422

Determine pharmacokinetic profile (Cmin) of REM-422

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Adenoid Cystic Carcinoma (ACC) treatments often target specific genetic and molecular pathways to inhibit tumor growth and progression. One such treatment under investigation is REM-422, a MYB mRNA degrader, which works by reducing the levels of MYB mRNA, a gene implicated in the proliferation and survival of ACC cells. This targeted approach is crucial for ACC patients as it offers a more precise method to disrupt cancer cell function while potentially minimizing damage to normal cells. Other common treatments may include chemotherapy, radiation, and surgery, which aim to remove or destroy cancer cells but can have broader effects on the body. Targeted therapies like MYB mRNA degraders represent a promising advancement in providing more effective and less toxic treatment options for ACC patients.

Combinatorial Low Dose Arsenic Trioxide and Cisplatin Exacerbates Autophagy via AMPK/STAT3 Signaling on Targeting Head and Neck Cancer Initiating Cells.Cisplatin exposure causes c-Myc-dependent resistance to CDK4/6 inhibition in HPV-negative head and neck squamous cell carcinoma.Interplay of non-coding RNAs and approved antimetabolites such as gemcitabine and pemetrexed in mesothelioma.