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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

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004.
Evaluation of adverse events (AEs)
Evaluation of clinical chemistry laboratory parameters
+2 more
Secondary study objectives
Evaluation of overall survival (OS)
Evaluation of progression-free survival (PFS)
Evaluation of the objective response rate (ORR)

Trial Design

1Treatment groups
Experimental Treatment
Group I: PAS-004Experimental Treatment1 Intervention
Sequential dose escalation: 2 mg, 4 mg, 8 mg, 15 mg, 22 mg, 30 mg, 37 mg, and 45 mg

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Who is running the clinical trial?

Pasithea Therapeutics Corp.Lead Sponsor
Graeme Currie, PhDStudy DirectorPasithea Therapeutics Corp.
~28 spots leftby Dec 2025
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