PAS-004 for Advanced Solid Tumors

Phase 1

Recruiting

Research Sponsored by Pasithea Therapeutics Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up screening through day 1 through day 35 (cycle 1), and 30 days after discontinuation of study drug

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a drug called PAS-004 in people with advanced solid tumors that have specific mutations. It will evaluate how well participants tolerate different doses of PAS-004 and what side effects the

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects of PAS-004 may include typical drug reactions like nausea, fatigue, allergic responses, and possibly unique risks due to its action on RAS/RAF pathways which will be monitored closely during the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ screening through day 1 through day 35 (cycle 1), and 30 days after discontinuation of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~screening through day 1 through day 35 (cycle 1), and 30 days after discontinuation of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and screening through day 1 through day 35 (cycle 1), and 30 days after discontinuation of study drug for reporting.