Your session is about to expire
← Back to Search
FAK Inhibitor
Mirdametinib + BGB-3245 for Advanced Cancer
Phase 1 & 2
Recruiting
Research Sponsored by SpringWorks Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial tests an experimental combo drug to treat advanced cancer that has not responded to other treatments.
Who is the study for?
Adults with advanced solid tumors that haven't improved with at least one prior treatment, or when no other treatments are available. Participants must be over 18, have a performance status of ≤2 (which means they can do some light activity), and have specific genetic changes in their tumor related to the MAPK pathway. They should not have had recent cancer therapy or surgery, and cannot join if they have certain medical conditions like severe heart disease or uncontrolled infections.Check my eligibility
What is being tested?
The trial is testing a combination of two drugs: Mirdametinib and BGB-3245. It's an early-phase study where doses are increased gradually to find safe levels before expanding to more patients. The goal is to see how well these drugs work together against different types of solid tumors with mutations affecting cell growth pathways.See study design
What are the potential side effects?
Possible side effects include typical reactions from cancer therapies such as fatigue, digestive issues, skin problems, and changes in blood tests that reflect liver function. There may also be risks unique to these medications due to their action on specific cellular pathways involved in tumor growth.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of treatment emergent adverse events
Maximum Tolerated Dose (Part 1 Only)
Objective Response Rate (Part 2 Only)
+1 moreSecondary outcome measures
Body Weight Changes
Duration of Response Rate
Objective Response Rate (Part 1 Only)
Trial Design
4Treatment groups
Experimental Treatment
Group I: Phase 2 Dose Expansion CExperimental Treatment2 Interventions
Participants with NSCLC or cutaneous melanoma harboring BRAF Class II or Class III mutation or BRAF Fusion mutation
Group II: Phase 2 Dose Expansion BExperimental Treatment2 Interventions
Participants with NSCLC harboring KRAS mutations
Group III: Phase 2 Dose Expansion AExperimental Treatment2 Interventions
Participants with cutaneous melanoma harboring NRAS mutations
Group IV: Phase 1 Dose Escalation Cohorts Ranging in DoseExperimental Treatment2 Interventions
Participants with an oncogenic mutation or other genomic aberration of the MAPK pathway
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mirdametinib
2021
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
SpringWorks Therapeutics, Inc.Lead Sponsor
12 Previous Clinical Trials
830 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a parathyroid disorder or had cancer-related high calcium levels.I cannot swallow pills.I haven't had cancer treatment in the last 2 weeks or 5 half-lives.I have a history of glaucoma.My cancer has spread to my brain or spinal cord.I have not had serious heart problems in the last 6 months.I had to stop taking certain cancer drugs due to severe side effects.I do not have an active infection like HIV, Hepatitis B, or C.I have not received a live vaccine in the last 4 weeks.My organs are functioning well and I haven't had a transfusion in the last 14 days.I haven't taken systemic steroids or glucocorticoids in the last 2 weeks.I haven't taken strong CYP3A4 affecting drugs in the last 2 weeks.I am 18 years old or older.I can provide previous tumor samples or agree to a new biopsy.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.My cancer has a specific genetic change in the MAPK pathway.My cancer is advanced and didn't respond to or worsened after treatment.I do not have any severe or uncontrolled illnesses.I have a history of bleeding disorders like ITP or Von Willebrand disease.I can take care of myself and perform daily activities.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1 Dose Escalation Cohorts Ranging in Dose
- Group 2: Phase 2 Dose Expansion A
- Group 3: Phase 2 Dose Expansion B
- Group 4: Phase 2 Dose Expansion C
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research endeavor still being accepted?
"Per the information on clinicaltrials.gov, this investigation is not currently looking for participants. Initially posted in March 1st 2023 and last updated December 1st 2022, there are no patients openings available; however, 2502 other trials are actively recruiting individuals at present."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger