Colorectal Cancer Clinical Trial
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).
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Biomea Fusion Inc. |
United States, Korea, Republic of,
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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