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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

Adults with a confirmed diagnosis of unresectable, locally advanced and/or metastatic Stage IIIB/IV NSCLC, Stage III/IV PDAC and/or Stage III/IV CRC with no curative-intent treatment options and documented activating KRAS mutation (without known additional actionable driver mutations such as EGFR, ALK or ROS1)

Must not have

Significant cardiovascular disease or QTcF or QTcB prolongation

Prior menin inhibitor therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 46 months

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My cancer has grown after 1-4 treatments, and side effects from past treatments are minimal.

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I have advanced lung, pancreatic, or colorectal cancer with a specific KRAS mutation and no curative treatment options.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart disease or a known issue with my heart's electrical activity.

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I have previously received menin inhibitor therapy.

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I do not have any serious infections or health conditions.

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I do not have severe brain metastasis, lung disease, or fluid around my heart/lungs that needs constant oxygen.

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I need treatment with a specific type of medication that affects liver enzymes.

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I have not had any other cancer in the last 2 years.

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I have not had major surgery in the last 4 weeks.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 46 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~46 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 46 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.

Secondary study objectives

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.

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: 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).

0 / 10Eligibility criteria met