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

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.

Time frame: 46 months

To evaluate the pharmacokinetics of BMF-219.

Pharmacokinetics will be determined using maximum observed plasma concentration (Cmax ).

Time frame: 46 months

To evaluate the pharmacokinetics of BMF-219.

Pharmacokinetics will be determined time to maximum plasma concentration (tmax).

Time frame: 46 months

To evaluate the pharmacokinetics of BMF-219.

Pharmacokinetics will be determined using the AUC from time 0 to last quantifiable concentration (AUClast ).

Time frame: 46 months

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.

Time frame: 46 months

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.

Time frame: 46 months