Non Small Cell Lung CancerPhase 1NCT05631574
Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer
A Phase 1 study testing BMF-219 in people with Non Small Cell Lung Cancer and Pancreatic Cancer, run by Biomea Fusion Inc. at 23 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer
- What is being tested?
- BMF-219
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 12 Jan 2023to 15 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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
- ECOG PS of 0-2 (0-1 for PDAC) and a life expectancy > 3 months in the opinion of the Investigator
- Adequate hematological, liver, and renal function
- 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
Who cannot join
- 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
- Serious concomitant disorder including infection
- Known positive test for HIV, HCV, HBV surface antigen
- Concurrent malignancy in the previous 2 years
- Prior menin inhibitor therapy
- Requiring treatment with a strong or moderate CYP3A inhibitor/inducer
Show all 9Show fewer
- Significant cardiovascular disease or QTcF or QTcB prolongation.
- Major surgery within 4 weeks prior to first dose
- Women who are pregnant or lactating.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States19 sites
Cancer Treatment Centers of America - Atlanta
Atlanta, Georgia, 30269
Roswell Park Cancer Institute
Buffalo, New York, 14263
Robert H. Lurie Comprehensive Cancer Center of Northwestern Univeristy
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80237
California Cancer Associates for Research and Excellence (cCARE)
Encinitas, California, 92024
NEXT Virginia
Fairfax, Virginia, 22031
Cancer Treatment Centers of America - Phoenix
Goodyear, Arizona, 85338
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California, San Diego
La Jolla, California, 92037
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, 33140
Tennessee Oncology
Nashville, Tennessee, 37203
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Mayo Clinic
Rochester, Minnesota, 55905
NEXT Oncology
San Antonio, Texas, 78229
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University School of Medicine - Siteman Cancer Center
St Louis, Missouri, 63110
Cancer Treatment Centers of America - Chicago
Zion, Illinois, 60099
South Korea4 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital Yonsei University Health System - PPDS
Seoul, 03722
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
About this study
Official title: A Phase 1/1b Dose Finding Study of BMF-219, an Oral Covalent Menin Inhibitor, in Adult Patients With Unresectable, Locally Advanced, or Metastatic Non-small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PDAC), and Colorectal Cancer (CRC)
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).
Read the detailed description
This is a dose finding study to determine the safety and tolerability, pharmacokinetics and pharmacodynamics, and clinical activity of escalating doses of BMF-219 administered orally (PO) either once daily (QD) or twice daily (BID) in 28-day cycles. After observing acceptable safety performance in these dosing regimens, additional subjects will be enrolled to assess efficacy in the determination of the OBD for use as a RP2D.
- Conditions
- Non Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, NSCLC, PDAC, CRC
- Being tested
- BMF-219
- Keywords
- Oral Covalent Menin Inhibitor, Relapsed, Refractory, Irreversible Menin Inhibitor, Menin Inhibitor, Unresectable, Locally Advanced, Metastatic, Menin, Menin Therapy, KRAS, KRAS Mutated
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Pancreatic Neoplasms, Colorectal Neoplasms, Recurrence, Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMF-219Drug
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| Escalation Phase | Experimental | 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). Receives: Drug: BMF-219 |
| Expansion Phase | Experimental | 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. Receives: Drug: BMF-219 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
OBD/RP2D as determined by the number of subjects receiving BMF-219 monotherapy who experience Dose-Limiting Toxicities (DLTs) within each dose level. A DLT is defined as any clinically significant Adverse Event within 28 days of starting BMF-219 treatment and considered to be related to the IMP. Adverse Events will be assessed per CTCAE v5.0.
Measured: 30 months
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
OBD/RP2D as measured by objective response rate (ORR). ORR will be assessed using RECIST 1.1 per investigator assessment.
Measured: 30 months
Secondary outcomes (6)
To evaluate the safety and tolerability of BMF-219 monotherapy.
Safety and tolerability will be determined using treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) as outcomes.
Measured: 46 months
To evaluate the pharmacokinetics of BMF-219.
Pharmacokinetics will be determined using maximum observed plasma concentration (Cmax ).
Measured: 46 months
To evaluate the pharmacokinetics of BMF-219.
Pharmacokinetics will be determined time to maximum plasma concentration (tmax).
Measured: 46 months
To evaluate the pharmacokinetics of BMF-219.
Pharmacokinetics will be determined using the AUC from time 0 to last quantifiable concentration (AUClast ).
Measured: 46 months
To evaluate the efficacy of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
Efficacy will be determined using duration of response (DOR), defined by the duration of time from the date of initial response of PR or better to the date of disease progression or death due to any cause, whichever occurs first. DOR will be assessed using RECIST 1.1 per investigator assessment.
Measured: 46 months
To evaluate the efficacy of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
Efficacy determined by disease control rate (DCR), defined as the proportion of response-evaluable subjects who maintain disease control (Complete Response, Partial Response or SD as per RECIST 1.1) from first dose through Week 6.
Measured: 46 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start12 Jan 2023
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Why it stopped: Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- This study is an ascending multiple dose clinical trial followed by cohort expansion. The dose escalation part is primarily intended to identify the optimal biologic dose (OBD)(s) of BMF-219 and to obtain initial safety and tolerability information regarding the compound when administered orally to subjects with KRAS mutated unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC. This study will also evaluate the PK/PD profiles of multiple dose administration of BMF-219. Following completion of the dose escalation, cohort and arm-specific expansion cohorts will commence in order to further confirm the safety and tolerability of BMF-219 dosed at or near the OBD.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomea Fusion Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Morris, MD, Study director, Biomea Fusion Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631574
- Sponsor's protocol ID
- COVALENT-102
- Status last verified
- Feb 2025
- First submitted
- 4 Nov 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/1b Dose Finding Study of BMF-219, an Oral Covalent Menin Inhibitor, in Adult Patients With Unresectable, Locally Advanced, or Metastatic Non-small Cell Lung Cancer (NSCLC), Pancreatic Cancer (PDAC), and Colorectal Cancer (CRC)
- ClinicalTrials.gov ID
- NCT05631574
- Acronym / sponsor ID
- COVALENT-102
- Conditions
- Non Small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, NSCLC, PDAC, CRC
- Keywords
- Oral Covalent Menin Inhibitor, Relapsed, Refractory, Irreversible Menin Inhibitor, Menin Inhibitor, Unresectable, Locally Advanced, Metastatic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Biomea Fusion Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is a dose finding study to determine the safety and tolerability, pharmacokinetics and pharmacodynamics, and clinical activity of escalating doses of BMF-219 administered orally (PO) either once daily (QD) or twice daily (BID) in 28-day cycles. After observing acceptable safety performance in these dosing regimens, additional subjects will be enrolled to assess efficacy in the determination of the OBD for use as a RP2D.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is an ascending multiple dose clinical trial followed by cohort expansion. The dose escalation part is primarily intended to identify the optimal biologic dose (OBD)(s) of BMF-219 and to obtain initial safety and tolerability information regarding the compound when administered orally to subjects with KRAS mutated unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC. This study will also evaluate the PK/PD profiles of multiple dose administration of BMF-219. Following completion of the dose escalation, cohort and arm-specific expansion cohorts will commence in order to further confirm the safety and tolerability of BMF-219 dosed at or near the OBD.
| Arm | Type | Receives |
|---|---|---|
| Escalation Phase | Experimental | Drug: BMF-219Dose 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). |
| Expansion Phase | Experimental | Drug: BMF-219Dose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- 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
- ECOG PS of 0-2 (0-1 for PDAC) and a life expectancy > 3 months in the opinion of the Investigator
- Adequate hematological, liver, and renal function
Key exclusion criteria (9 listed)
- 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
- Serious concomitant disorder including infection
- Known positive test for HIV, HCV, HBV surface antigen
- Concurrent malignancy in the previous 2 years
- Prior menin inhibitor therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMF-219BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor. | Drug | Escalation Phase, Expansion Phase |
Primary outcome
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
Time frame: 30 months
OBD/RP2D as determined by the number of subjects receiving BMF-219 monotherapy who experience Dose-Limiting Toxicities (DLTs) within each dose level. A DLT is defined as any clinically significant Adverse Event within 28 days of starting BMF-219 treatment and considered to be related to the IMP. Adverse Events will be assessed per CTCAE v5.0.
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
Time frame: 30 months
OBD/RP2D as measured by objective response rate (ORR). ORR will be assessed using RECIST 1.1 per investigator assessment.
6 secondary outcomes
To evaluate the safety and tolerability of BMF-219 monotherapy.
Time frame: 46 months
To evaluate the pharmacokinetics of BMF-219.
Time frame: 46 months
To evaluate the pharmacokinetics of BMF-219.
Time frame: 46 months
To evaluate the pharmacokinetics of BMF-219.
Time frame: 46 months
To evaluate the efficacy of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
Time frame: 46 months
To evaluate the efficacy of BMF-219 monotherapy in subjects with unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC.
Time frame: 46 months
Results and safety
The study was stopped early (reason given: Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Morris, MD study director
Biomea Fusion Inc.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMF-219 in people with Non Small Cell Lung Cancer and Pancreatic Cancer, run by Biomea Fusion Inc. at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Biomea Fusion, Inc., is no longer pursuing oncology indications for BMF-219. No safety concerns or efficacy observations led to this study closure.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic NSCLC, PDAC and CRC. (time frame: 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.