PAS-004 in Patients With Advanced Solid Tumors

The main purpose of this clinical trial is to test PAS-004 in people with advanced solid tumors with rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF) mutations. The main questions it aims to answer are: * How well participants are able tolerate different doses of PAS-004, and * What side effects PAS-004 might have. Study participants will have regular visits to the study doctor and be asked to have tests and exams done to check on their health and safety. Everyone participating in the study will take PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles. Participants will continue on daily PAS-004 for up to 2 years, or until: * They decide to withdraw from the study, or * They experience unacceptable side effects, or * Their disease progresses, or another illness interferes with taking the study drug, or * The sponsors stops the study.

NCT Number	NCT06299839
Lead Sponsor	Pasithea Therapeutics Corp.
Conditions	RAS Mutation, NF1 Mutation, RAF Mutation, Advanced Solid Tumors
Enrollment	48 participants
Start Date	2024-02-29
Primary Completion	2026-02 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2025-12-03