Trial Title:
Study of Covalent Menin Inhibitor BMF-219 in Adult Patients With KRAS Driven Non-Small Cell Lung Cancer, Pancreatic Cancer, and Colorectal Cancer
NCT ID:
NCT05631574
Condition:
Non Small Cell Lung Cancer
Pancreatic Cancer
Colorectal Cancer
NSCLC
PDAC
CRC
Relapsed Cancer
Refractory Cancer
Stage III Pancreatic Cancer
Stage IV Pancreatic Cancer
Stage III Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Stage III Colorectal Cancer
Stage IV Colorectal Cancer
Stage III NSCLC
Stage IV NSCLC
KRAS Mutation-Related Tumors
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Pancreatic Neoplasms
Conditions: Keywords:
Oral Covalent Menin Inhibitor
Relapsed
Refractory
Irreversible Menin Inhibitor
Menin Inhibitor
Unresectable
Locally Advanced
Metastatic
Menin
Menin Therapy
KRAS
KRAS Mutated
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMF-219
Description:
BMF-219 is an orally bioavailable, covalent small-molecule menin inhibitor.
Arm group label:
Escalation Phase
Arm group label:
Expansion Phase
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).
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Treatment Centers of America - Phoenix
Address:
City:
Goodyear
Zip:
85338
Country:
United States
Status:
Recruiting
Facility:
Name:
California Cancer Associates for Research and Excellence (cCARE)
Address:
City:
Encinitas
Zip:
92024
Country:
United States
Status:
Recruiting
Facility:
Name:
University of California, San Diego
Address:
City:
La Jolla
Zip:
92037
Country:
United States
Status:
Recruiting
Facility:
Name:
Sarah Cannon Research Institute at HealthONE
Address:
City:
Denver
Zip:
80237
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Mount Sinai Comprehensive Cancer Center
Address:
City:
Miami Beach
Zip:
33140
Country:
United States
Status:
Recruiting
Facility:
Name:
Cancer Treatment Centers of America - Atlanta
Address:
City:
Atlanta
Zip:
30269
Country:
United States
Status:
Recruiting
Facility:
Name:
Robert H. Lurie Comprehensive Cancer Center of Northwestern Univeristy
Address:
City:
Chicago
Zip:
60611
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Cancer Treatment Centers of America - Chicago
Address:
City:
Zion
Zip:
60099
Country:
United States
Status:
Recruiting
Facility:
Name:
Mayo Clinic
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Washington University School of Medicine - Siteman Cancer Center
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Nebraska Medical Center
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Facility:
Name:
Ohio State University
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Facility:
Name:
Tennessee Oncology
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Vanderbilt Ingram Cancer Center
Address:
City:
Nashville
Zip:
37232
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
The University of Texas MD Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Facility:
Name:
Samsung Medical Center
Address:
City:
Gangnam-Gu
Zip:
06351
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Seoul National University Hospital
Address:
City:
Jongno-gu
Zip:
03080
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
The Catholic University of Korea, Seoul St. Mary's Hospital
Address:
City:
Seocho-gu
Country:
Korea, Republic of
Status:
Not yet recruiting
Facility:
Name:
Severance Hospital Yonsei University Health System - PPDS
Address:
City:
Seodaemun-gu
Zip:
03722
Country:
Korea, Republic of
Status:
Not yet recruiting
Start date:
January 12, 2023
Completion date:
October 2026
Lead sponsor:
Agency:
Biomea Fusion Inc.
Agency class:
Industry
Source:
Biomea Fusion Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05631574
