Experimental combo for Hard-to-Treat cancers shows early promise but study halted
NCT ID NCT05580770
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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23 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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Jan 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Calvary Mater Newcastle
Waratah, 2298, Australia
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Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
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UC San Diego Moores Cancer Center
La Jolla, California, 92093, United States
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
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Yale-New Haven Hospital-Yale Cancer Center
New Haven, Connecticut, 06520, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Oral drug that targets two cancer drivers tested in first human study
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Can a Two-Drug combo outsmart advanced cancer?
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- New injectable drug tested for safety in Hard-to-Treat solid tumors