Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

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).

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)

Details

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.

Keywords

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, Oral Covalent Menin Inhibitor, Relapsed, Refractory, Irreversible Menin Inhibitor, Menin Inhibitor, Unresectable, Locally Advanced, Metastatic, Menin, Menin Therapy, KRAS, KRAS Mutated, Lung Neoplasms, Non-Small-Cell Lung Carcinoma, Colorectal Neoplasms, Pancreatic Neoplasms, BMF-219

Eligibility

You can join if…

Open to people ages 18 years and up

  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

  1. ECOG PS of 0-2 (0-1 for PDAC) and a life expectancy > 3 months in the opinion of the Investigator
  2. Adequate hematological, liver, and renal function
  3. 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

You CAN'T join if...

  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 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.

Locations

  • University of California, San Diego not yet accepting patients
    La Jolla California 92037 United States
  • California Cancer Care Associates not yet accepting patients
    Encinitas California 92024 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Biomea Fusion Inc.
ID
NCT05631574
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated