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Recruiting Phase 1 NCT06299839

PAS-004 in Patients With Advanced Solid Tumors

Trial Parameters

Condition RAS Mutation
Sponsor Pasithea Therapeutics Corp.
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 48
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-02-29
Completion 2026-02
Interventions
PAS-004 CapsulesPAS-004 Tablets

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Capable of giving signed informed consent which includes compliance with the requirements, prohibitions and restrictions listed in the informed consent form (ICF). 2. Patient has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits, the potential risks, and the discomfort to which they may be exposed and has given written consent to participation in the study prior to study start and any study-related procedure. 3. Patient must be at least 18 years of age at the time of signing the ICF. 4. Patient must be able to swallow oral medication. 5. Patient with histologically or cytologically diagnosed mitogen-activated protein kinase (MAPK) pathway driven advanced solid tumors with all of the following characteristics: 1. Tumor cannot be surgically resected 2. Patient has failed or is ineligible for standard of care therapy 3. Patient has no available treatment options with known clinical benefit 4.

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