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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05631574
Other study ID # COVALENT-102
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date January 12, 2023
Est. completion date October 2026

Study information

Verified date December 2023
Source Biomea Fusion Inc.
Contact Alex Cacovean, MD
Phone 1-844-245-0490
Email clinicaltrials@biomeafusion.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date October 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion 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 Exclusion 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.

Study Design


Related Conditions & MeSH terms

  • Carcinoma, Non-Small-Cell Lung
  • Colorectal Cancer
  • Colorectal Neoplasms
  • CRC
  • KRAS Mutation-Related Tumors
  • Lung Neoplasms
  • Non Small Cell Lung Cancer
  • NSCLC
  • Pancreatic Cancer
  • Pancreatic Neoplasms
  • PDAC
  • Refractory Cancer
  • Relapsed Cancer
  • Stage III Colorectal Cancer
  • Stage III Non-small Cell Lung Cancer
  • Stage III NSCLC
  • Stage III Pancreatic Cancer
  • Stage IV Colorectal Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Stage IV NSCLC
  • Stage IV Pancreatic Cancer

Intervention

Drug:
BMF-219
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Gangnam-Gu Seoul
Korea, Republic of Seoul National University Hospital Jongno-gu Seoul
Korea, Republic of The Catholic University of Korea, Seoul St. Mary's Hospital Seocho-gu Seoul
Korea, Republic of Severance Hospital Yonsei University Health System - PPDS Seodaemun-gu Seoul
United States Cancer Treatment Centers of America - Atlanta Atlanta Georgia
United States Roswell Park Cancer Institute Buffalo New York
United States Robert H. Lurie Comprehensive Cancer Center of Northwestern Univeristy Chicago Illinois
United States Ohio State University Columbus Ohio
United States Sarah Cannon Research Institute at HealthONE Denver Colorado
United States California Cancer Associates for Research and Excellence (cCARE) Encinitas California
United States NEXT Virginia Fairfax Virginia
United States Cancer Treatment Centers of America - Phoenix Goodyear Arizona
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States University of California, San Diego La Jolla California
United States Mount Sinai Comprehensive Cancer Center Miami Beach Florida
United States Tennessee Oncology Nashville Tennessee
United States Vanderbilt Ingram Cancer Center Nashville Tennessee
United States University of Nebraska Medical Center Omaha Nebraska
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine - Siteman Cancer Center Saint Louis Missouri
United States NEXT Oncology San Antonio Texas
United States Fred Hutchinson Cancer Center Seattle Washington
United States Cancer Treatment Centers of America - Chicago Zion Illinois

Sponsors (1)

Lead Sponsor Collaborator
Biomea Fusion Inc.

Countries where clinical trial is conducted

United States,  Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 30 months
Primary 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. 30 months
Secondary 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. 46 months
Secondary To evaluate the pharmacokinetics of BMF-219. Pharmacokinetics will be determined using maximum observed plasma concentration (Cmax ). 46 months
Secondary To evaluate the pharmacokinetics of BMF-219. Pharmacokinetics will be determined time to maximum plasma concentration (tmax). 46 months
Secondary To evaluate the pharmacokinetics of BMF-219. Pharmacokinetics will be determined using the AUC from time 0 to last quantifiable concentration (AUClast ). 46 months
Secondary 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. 46 months
Secondary 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. 46 months
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