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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).

Description

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).

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this trial is to determine the OBDs/RP2Ds of BMF-219 monotherapy in subjects with KRAS-driven unresectable, locally advanced, or metastatic non-small cell lung cancer, pancreatic cancer and colorectal cancer.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who meet this 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 ≥ one 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 > three 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

Excluding patients who meet this 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 therapy
  • Requiring treatment with a strong or moderate CYP3A inhibitor/inducer
  • Significant cardiovascular disease or QTcF or QTcB prolongation.
  • Major surgery within four weeks prior to first dose
  • Women who are pregnant or lactating.