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Mitogens

Sequential dose escalation: 2 mg, 4 mg, 6 mg, 9 mg, 12 mg, 15 mg, and 18 mg

A mitogen-activated protein kinase/extracellular signal-regulated kinase kinase (MAPK/ERK kinase, or MEK) 1/2 inhibitor presented in 1 mg and 10 mg strength capsules, intended for oral administration once daily.

PAS-004

Erica Torres

Carmen Gonzalez

Blake Patterson

Graeme Currie, PhD

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.

PAS-004 in Patients With Advanced Solid Tumors

A Phase 1 Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAS-004, a MEK (1/2) Inhibitor, in Patients With MAPK Pathway-driven Advanced Solid Tumors With a Documented RAS, NF1, or RAF Mutation or Patients Who Have Failed BRAF/MEK Inhibition

Pre-defined DLTs will be assessed for dose escalation and expansion determinations.

The number and severity of AEs will be evaluated for dosing cohorts to inform dose escalation and expansion decisions, and support selection of a preliminary recommended phase 2 dose (RP2D).

The number and severity of AEs leading to discontinuation of study drug will be evaluated for dosing cohorts to inform dose escalation and expansion decisions, and support selection of a preliminary recommended phase 2 dose (RP2D).

Lab parameters will be evaluated for to assess the safety profile of the study drug, and support selection of a preliminary recommended phase 2 dose (RP2D).

The proportion of participants achieving a partial response (PR) or complete response (CR) per response evaluation criteria in solid tumors (RECIST) 1.1 criteria.

The time from first dose of IP to the date of documented disease progression or date of death due to any cause (whichever occurs first).

The time from first dose of IP to the date of death due to any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
PAS-004 in Patients With Advanced Solid Tumors	NCT06299839	RAS Mutation NF1 Mutation RAF Mutation Advanced Solid ...	PAS-004	18 Years -	Pasithea Therapeutics Corp.
PAS-004 in Patients With Advanced Solid Tumors	NCT06299839	RAS Mutation NF1 Mutation RAF Mutation Advanced Solid ...	PAS-004	18 Years -	Pasithea Therapeutics Corp.

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