TerminatedPhase 1NCT05631574
Official study title

Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer

Study summary

A Phase 1/1b dose finding study to determine the OBD(s) and RP2D(s) of BMF-219, a covalent menin inhibitor small molecule, in subjects with KRAS mutated unresectable, locally advanced, or metastatic NSCLC (Cohort 1), PDAC (Cohort 2), and CRC (Cohort 3).

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBMF-219

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 7, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?23 U.S. locations

Locations may change over time.

Who runs it?Biomea Fusion Inc.

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 1
Sponsor
Biomea Fusion Inc.
Interventions being studied
Drug: BMF-219
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. 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) 2. 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 3. ECOG PS of 0-2 (0-1 for PDAC) and a life expectancy \> 3 months in the opinion of the Investigator 4. Adequate hematological, liver, and renal function 5. 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

Reasons someone may not be able to joinExclusion criteria

1. Symptomatic and/or untreated CNS or brain metastasis, pre-existing ILD or pericardial/pleural effusion of ≥ grade 2 or requiring chronic oxygen therapy for COPD or pleural effusions 2. Serious concomitant disorder including infection 3. Known positive test for HIV, HCV, HBV surface antigen 4. Concurrent malignancy in the previous 2 years 5. Prior menin inhibitor therapy 6. Requiring treatment with a strong or moderate CYP3A inhibitor/inducer 7. Significant cardiovascular disease or QTcF or QTcB prolongation. 8. Major surgery within 4 weeks prior to first dose 9. Women who are pregnant or lactating.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Cancer Treatment Centers of America - PhoenixGoodyear, Arizona
  • California Cancer Associates for Research and Excellence (cCARE)Encinitas, California
  • University of California, San DiegoLa Jolla, California
  • Sarah Cannon Research Institute at HealthONEDenver, Colorado
  • Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida
  • Cancer Treatment Centers of America - AtlantaAtlanta, Georgia
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern UniveristyChicago, Illinois
  • Cancer Treatment Centers of America - ChicagoZion, Illinois
  • Mayo ClinicRochester, Minnesota
  • Washington University School of Medicine - Siteman Cancer CenterSt Louis, Missouri
  • University of Nebraska Medical CenterOmaha, Nebraska
  • Roswell Park Cancer InstituteBuffalo, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 7, 2025. Always confirm current availability with the study team.

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