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Kinase Inhibitor

Lifirafenib + Mirdametinib for Cancer

Phase 1
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Oncology Group performance status of less than or equal to 1
Advanced or metastatic, unresectable tumors (other than patients with tumors of the brain or central nervous system) who have experienced disease progression
Must not have
Hemorrhage or bleeding event at NCI-CTCAE v5.0 Grade 3 or higher within 28 days of first dose
LVEF less than 50%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years from date of the participants enrollment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a combination of two experimental drugs, lifirafenib and mirdametinib, in people with tumors. The goal is to see if these drugs can work together to stop or slow down tumor growth by blocking signals that cancer cells need to grow.

Who is the study for?
Adults with advanced solid tumors who can provide a tumor sample and consent, have a life expectancy over 12 weeks, measurable disease per RECIST 1.1, good performance status (ECOG ≤1), adequate organ function, and agree to use contraception can join. Exclusions include CNS metastasis, certain heart conditions, abnormal QT interval on ECG, active liver disease or infections like HIV/Hepatitis B/C.
What is being tested?
The trial is testing the combination of two drugs: Lifirafenib (BGB-283) and Mirdametinib (PD-0325901) in adults with various types of advanced solid tumors. It's designed to assess safety and how the body processes these drugs.
What are the potential side effects?
Potential side effects may include typical reactions seen with cancer treatments such as fatigue, nausea, skin rash or other allergic reactions. Specific risks related to Lifirafenib or Mirdametinib will be monitored based on their known profiles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my self-care but cannot do heavy physical work.
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My cancer has spread, cannot be surgically removed, and is getting worse.
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I am a male who is either vasectomized or agrees to use contraception.
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I can provide previous tumor samples or agree to a new biopsy.
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I am at least 18 years old or of legal age in my area to consent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't had severe bleeding in the last 28 days.
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My heart's pumping ability is below normal.
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My cancer has spread to my brain.
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I haven't had major surgery or serious injuries in the last 4 weeks and don't expect to need major surgery during the study.
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I had to stop taking certain cancer drugs due to severe side effects.
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I have not received a live vaccine in the last 4 weeks, except for flu and COVID-19 shots.
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I have a severe illness that is not under control.
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I do not have an active or known history of significant liver disease.
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I have an eye condition that could lead to central vision loss.
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I have a history of bleeding disorders, including Von Willebrand disease.
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I cannot swallow pills.
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I have a parathyroid disorder or had cancer-related high calcium levels.
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I have a history of glaucoma.
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I am not taking any strong medications that affect liver enzymes.
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I haven't had radiation or certain cancer treatments in the last 4 weeks.
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I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years from date of the participants enrollment
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years from date of the participants enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse Events and Serious Adverse Events

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part B: ExpansionExperimental Treatment2 Interventions
Approximately 20 participants with NRAS mutated solid tumors will be enrolled
Group II: Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens.Experimental Treatment2 Interventions
Combination doses of, Mirdametinib at once a day and lifirafenib at once a day And Mirdametinib at twice a day and lifirafenib at once a day

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
The RAF/MEK/ERK signaling pathway is essential for cell division and survival, and its dysregulation is commonly associated with cancer. RAF kinase inhibitors, like lifirafenib, inhibit RAF proteins, preventing the activation of downstream MEK and ERK proteins. MEK inhibitors, such as mirdametinib, directly inhibit MEK proteins, blocking the pathway further. This dual inhibition can effectively reduce tumor cell proliferation and growth, making it a promising treatment strategy for patients with solid tumors.

Find a Location

Who is running the clinical trial?

BeiGeneLead Sponsor
199 Previous Clinical Trials
30,915 Total Patients Enrolled
SpringWorks Therapeutics, Inc.Industry Sponsor
12 Previous Clinical Trials
748 Total Patients Enrolled
Katie WoodStudy DirectorBeiGene
2 Previous Clinical Trials
367 Total Patients Enrolled

Media Library

Lifirafenib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03905148 — Phase 1
Solid Tumors Research Study Groups: Part A: Dose Escalation/Dose finding Dose Level Cohorts ranging in dose levels and dose regimens., Part B: Expansion
Solid Tumors Clinical Trial 2023: Lifirafenib Highlights & Side Effects. Trial Name: NCT03905148 — Phase 1
Lifirafenib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03905148 — Phase 1
~12 spots leftby Sep 2025