Phase 1 Study of PAS-004, a MEK Inhibitor, in Adults with Advanced Solid Tumors Having RAS, NF1, or RAF Mutations

What this Trial Is About

Researchers are evaluating PAS-004, a MEK 12 inhibitor, in adults with advanced solid tumors driven by mutations in rat sarcoma virus RAS, neurofibromatosis type I NF1, or rapidly accelerated fibrosarcoma RAF. The study focuses on how well participants tolerate different doses of PAS-004 and the side effects it may cause. This Phase 1 trial is led by Pasithea Therapeutics Corp. and involves patients with tumors that cannot be surgically removed and who have no effective treatment options left. Participants will take PAS-004 orally once daily in 28-day cycles, starting with a single dose followed by a week of observation. The study uses sequential dose escalation from 2 mg up to 45 mg in capsule form, with a separate group receiving 4 mg tablets. Participants may continue treatment for up to two years or until withdrawal, unacceptable side effects, disease progression, other illnesses interfere, or the study ends. During the study, participants will have regular visits to the doctor for tests, exams, and blood work to monitor safety, drug levels in the blood, and effects on tumors. Key outcomes include dose limiting toxicities, adverse events, pharmacokinetics, tumor response, progression-free survival, and overall survival. Safety follow-up continues for 30 days after stopping the drug, and participants health is closely observed throughout the trial period.

PAS-004 in Patients With Advanced Solid Tumors