PAS-004 in Patients With Advanced Solid Tumors

Part of paid clinical trials in Austin, Texas.

Sponsor
Pasithea Therapeutics Corp.
Study ID
NCT06299839
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors
  • NF1 Mutation
  • RAF Mutation
  • RAS Mutation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PAS-004 Capsules — DRUG
    A mitogen-activated protein kinase/extracellular signal-regulated kinase kinase (MAPK/ERK kinase, or MEK) 1/2 inhibitor presented in 1 mg, 4mg, and 10 mg strength capsules, intended for oral administration once daily.
  • PAS-004 Tablets — DRUG
    A mitogen-activated protein kinase/extracellular signal-regulated kinase kinase (MAPK/ERK kinase, or MEK) 1/2 inhibitor presented in 4mg strength tablets, intended for oral administration once daily.

Study Details

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.

Key Dates

Start date
Feb 29, 2024
Status verified
Nov 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PAS-004 Capsules
    Sequential dose escalation: 2 mg, 4 mg, 8 mg, 15 mg, 22 mg, 30 mg, 37 mg, and 45 mg
  • Experimental: PAS-004 Tablets
    A single cohort at the 4mg dose using tablet formulation of PAS-004

Primary Outcome Measure

Evaluation of dose limiting toxicities (DLTs) [ Time Frame: Day 1 through Day 35 (Cycle 1) ]

Locations (4)

FacilityCityStateZIPSite coordinators
NEXT OncologyAustinTexas78758-
NEXT OncologyIrvingTexas75039-
NEXT OncologySan AntonioTexas78229-
NEXT OncologyFairfaxVirginia22031-

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By research site
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