Ensem Therapeutics
This is a Phase 1/2, open-label, multi-center study to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of ETX-929 in participants with advanced solid tumors harboring a Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation.
Part A will evaluate escalating doses of ETX-929 as monotherapy in participants with advanced solid tumors. Part B will evaluate escalating doses of ETX-929 as combination therapy with fixed dose cetuximab in participants. Part C and Part D will expand enrollment of ETX-929 as monotherapy and in combination with cetuximab at the recommended doses from escalation. Each study part will include a 28-day screening period, followed by treatment with ETX-929 monotherapy or combination therapy.
Inclusion Criteria: * Metastatic or locally advanced and unresectable solid tumor that has progressed on or after at least one available therapy. * Tumor harboring a KRAS mutation. * An ECOG performance status score of 0 or 1. * Adequate organ function. Exclusion Criteria: * Has history (within ≤2 years before screening) of a solid tumor or hematological malignancy that is histologically distinct from the cancers being studied. * Has symptomatic brain or spinal metastases or a known or suspected history of untreated or uncontrolled central nervous system (CNS) involvement. * Has received tr…
ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule that will be taken once per day in 21-day cycles, to evaluate escalating dose levels.
ETX-929 is a pan-KRAS Inhibitor in the form of an oral capsule. ETX-929 will be taken in combination with cetuximab in 28-day cycles, to evaluate escalating dose levels. EXT-929 is an oral capsule that will be taken once per day. Cetuximab will be administered intravenously every two weeks.
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