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Experimental combo for Hard-to-Treat cancers shows early promise but study halted

NCT ID NCT05580770

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This early-phase trial tested a combination of two oral drugs, mirdametinib and brimarafenib, in 23 adults with advanced solid tumors that had stopped responding to standard treatments. The goal was to check safety, find the best dose, and see if the combo could shrink tumors. The study was terminated early, so results are limited, but the data may help guide future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mirdametinib and brimarafenib (BGB-3245) combination
What this could lead to
If successful, this combination could offer a new treatment option for people with advanced solid tumors that have not responded to other therapies.
What could go wrong
This was a very early (Phase 1/2a) study with only 23 participants, and it was terminated early. The combination may cause side effects and may not shrink tumors effectively.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

23 people

The number who actually took part.

Started

Feb 2023

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Able to provide informed consent * At least 18 years of age on day of signing ICF * Advanced, metastatic or unresectable solid cancer that has not responded to or progressed during or after at least 1 line of appropriate therapy or for which there is no treatment available or prior therapy was not tolerated. * Part 1: oncogenic mutation or other genomic aberration of the MAPK pathway * Part 2: oncogenic mutation or genomic aberration defined below: * Cohort A: cutaneous melanoma harboring NRAS mutations. * Cohort B: non-small cell lung cancer (NSCLC) harboring a KRAS mutation. * Cohort C: NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutations or BRAF Fusion mutation. * Must have archival tumor tissue or agree to a fresh tumor biopsy at screening * Measurable disease per RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * Adequate organ function and no transfusion within 14 days of first dose Key Exclusion Criteria: * Central Nervous System metastases, leptomeningeal carcinomatosis or untreated spinal cord compression * History of glaucoma * Active parathyroid disorder or history of malignancy associated hypercalcemia * Clinically significant cardiac disease within the past 6 months of signing ICF * History of toxicity from another RAF, MEK, ERK inhibitor requiring discontinuation of treatment from these agents * Severe or uncontrolled systemic disease * Inability to swallow oral medications * Clinically significant active infection (HIV, Hepatitis B or Hepatitis C) * History of or ongoing Immune Thrombocytopenia (ITP), Von Willebrand disease and/or other past or present bleeding disorders * Underlying medical conditions in investigator's opinion to be unfavorable to be a part of the study * Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose or anticipates need for major surgery while on study * Systemic anti-cancer therapy within 2 weeks or 5 half-lives before first dose * Concomitant systemic or glucocorticoid therapy within 2 weeks before first dose * Concomitant medicines that are strong CYP3A4 inhibitors or inducers within 2 weeks or 5 half-lives before first dose * Live vaccine within 4 weeks before first dose

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Calvary Mater Newcastle

    Waratah, 2298, Australia

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246, United States

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093, United States

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • Yale-New Haven Hospital-Yale Cancer Center

    New Haven, Connecticut, 06520, United States

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