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Covalent Menin Inhibitor
BMF-219 for Lung Cancer
Phase 1
Recruiting
Research Sponsored by Biomea Fusion Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented progression and measurable disease after ≥ 1 prior line of systemic therapy (≥ 2 and ≤ 4 prior lines for NSCLC) with adequate washout period and resolution of treatment-related toxicities to ≤ Grade 2
Men and women of childbearing potential must use adequate birth control measures for the duration of the trial and at least 90 days after discontinuing study treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 46 months
Awards & highlights
Study Summary
This trial is testing a drug to treat KRAS-mutated cancer, including lung, pancreatic and colon cancer.
Who is the study for?
Adults with advanced stages of NSCLC, PDAC, or CRC that can't be surgically removed and have KRAS mutations. They must have tried at least one systemic therapy before (up to four for NSCLC), be in a stable condition without serious infections or heart issues, not pregnant or breastfeeding, and willing to use birth control.Check my eligibility
What is being tested?
The trial is testing BMF-219's optimal dosages for safety and effectiveness. It targets adults with specific types of cancer (NSCLC, PDAC, CRC) that are linked to KRAS gene changes. The study will find the right dose by starting low and adjusting as needed.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical reactions to cancer drugs such as nausea, fatigue, liver function changes, blood count variations; plus risks from inhibiting menin like hormonal imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has grown after 1-4 treatments, and side effects from past treatments are minimal.
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I am using effective birth control and will continue for 90 days after the trial ends.
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I have advanced lung, pancreatic, or colorectal cancer with a specific KRAS mutation and no curative treatment options.
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My blood, liver, and kidney functions are within normal ranges.
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I can care for myself and am expected to live more than 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 46 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~46 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
Secondary outcome measures
To evaluate the efficacy of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
To evaluate the pharmacokinetics of BMF-219.
To evaluate the safety and tolerability of BMF-219 monotherapy.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Expansion PhaseExperimental Treatment1 Intervention
Dose Expansion Phase will enroll additional subjects independently in each disease indication:
Cohort 1: Participants with NSCLC
Cohort 2: Participants with PDAC
Cohort 3: Patients with CRC
Cohorts 1, 2, and 3 will receive BMF-219 at the OBD/ RP2D to further assess the safety and efficacy of the investigational drug.
Group II: Escalation PhaseExperimental Treatment1 Intervention
Dose Escalation Phase will group all disease indications (NSCLC, PDAC, and CRC) together to assess the safety of each dose level.
Participants will receive escalating dose BMF-219 orally once per day or twice per day to identify the OBD/RP2D (Optimal Biologic Dose/Recommended Ph2 Dose).
Find a Location
Who is running the clinical trial?
Biomea Fusion Inc.Lead Sponsor
4 Previous Clinical Trials
625 Total Patients Enrolled
Stephan Morris, MDStudy DirectorBiomea Fusion Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am using effective birth control and will continue for 90 days after the trial ends.I have previously received menin inhibitor therapy.My cancer has grown after 1-4 treatments, and side effects from past treatments are minimal.I have serious heart disease or a known issue with my heart's electrical activity.I have advanced lung, pancreatic, or colorectal cancer with a specific KRAS mutation and no curative treatment options.You have tested positive for HIV, HCV, or HBV.I do not have any serious infections or health conditions.I do not have severe brain metastasis, lung disease, or fluid around my heart/lungs that needs constant oxygen.I need treatment with a specific type of medication that affects liver enzymes.I have not had any other cancer in the last 2 years.I have not had major surgery in the last 4 weeks.My blood, liver, and kidney functions are within normal ranges.I am not pregnant or breastfeeding.I can care for myself and am expected to live more than 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Escalation Phase
- Group 2: Expansion Phase
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.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT05631574 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
In what geographic locations can prospective participants access this trial?
"Patients are being accepted to participate at Roswell Park Cancer Institute in Buffalo, New york; NEXT Oncology in San Antonio, Texas; Fred Hutch, University of Washington in Seattle, California and a couple other sites."
Answered by AI
Has the Escalation Phase received regulatory approval from the FDA?
"Due to the fledgling nature of Escalation Phase, our team has rated its safety at a 1. This is due to limited data supporting both efficacy and security checks."
Answered by AI
Is this examination still accepting new participants?
"The records hosted on clinicaltrials.gov suggest that this trial, first published on December 1st 2022 and last updated November 20th 2022, is no longer in need of participants. However, there are still 3686 other medical studies currently open for enrolment."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
Sarah Cannon Research Institute at HealthONE
Mayo Clinic
NEXT Oncology
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
looking for life longevity or a cure.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- NEXT Oncology: < 48 hours
Average response time
- < 2 Days
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