PAS-004 for Advanced Solid Tumors

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pasithea Therapeutics Corp.

Must not be taking: CYP3A inhibitors, QTc prolonging

Disqualifiers: CNS metastases, Cardiac disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

48 Participants Needed

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.

Research Team

Tiago R Marques, MD

Principal Investigator

Pasithea Therapeutics Corp.

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.

Inclusion Criteria

I can swallow pills.

I agree to use effective birth control or remain abstinent during and for 90 days after treatment.

I understand the study's goals, methods, benefits, risks, and have given written consent.

Exclusion Criteria

I haven't had cancer treatment or major surgery in the last 4 weeks.

I have conditions that affect how my body absorbs medication.

Participation in another therapeutic clinical trial within 4 weeks of enrollment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PAS-004 by mouth as a single dose, followed by one week observation, then once a day during the study, in 28-day cycles

Up to 2 years

Regular visits to the study doctor

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after discontinuation of study drug

Extension

Participants may continue treatment until they decide to withdraw, experience unacceptable side effects, or their disease progresses

Up to 2 years

Treatment Details

Interventions

• PAS-004

Trial Overview 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.

Participant Groups

Group I: PAS-004 Tablets Experimental Treatment 1 Intervention

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

Group II: PAS-004 Capsules Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Pasithea Therapeutics Corp.

Lead Sponsor

Trials

1

Recruited

50+