PAS-004 for Advanced Solid Tumors

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Pasithea Therapeutics Corp.

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot take certain medications like strong CYP3A inhibitors or inducers, or QTc interval prolonging medications close to starting the trial. It's best to discuss your current medications with the study doctor.

Eligibility Criteria

This trial is for adults with advanced solid tumors that have specific genetic changes (RAS, NF1, or RAF mutations). Participants should be able to swallow pills and attend regular study visits. They must not have other medical conditions that could interfere with the study or be taking certain medications.

Participant Groups

PAS-004 is being tested in this trial. It's a medication taken by mouth as a single dose initially, then daily in 28-day cycles for up to two years unless side effects become too severe or the disease gets worse. The goal is to find out how much of PAS-004 can be safely taken and what its potential side effects are.

2Treatment groups

Experimental Treatment

Group I: PAS-004 TabletsExperimental Treatment1 Intervention

A single cohort at the 4mg dose using tablet formulation of PAS-004

Group II: PAS-004 CapsulesExperimental Treatment1 Intervention

Sequential dose escalation: 2 mg, 4 mg, 8 mg, 15 mg, 22 mg, 30 mg, 37 mg, and 45 mg