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

B

Biomea Fusion

Status and phase

Enrolling
Phase 1

Conditions

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

Treatments

Drug: BMF-219

Study type

Interventional

Funder types

Industry

Identifiers

NCT05631574
COVALENT-102

Details and patient eligibility

About

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).

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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
  • Significant cardiovascular disease or QTcF or QTcB prolongation.
  • Major surgery within 4 weeks prior to first dose
  • Women who are pregnant or lactating.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

90 participants in 2 patient groups

Escalation Phase
Experimental group
Description:
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).
Treatment:
Drug: BMF-219
Expansion Phase
Experimental group
Description:
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.
Treatment:
Drug: BMF-219

Trial contacts and locations

23

Loading...

Central trial contact

Alex Cacovean, MD; Tracy Tong

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems