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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 09 Jul 2026

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At a glance

  • Drugs PAS 004 (Primary)
  • Indications Colorectal cancer; Malignant melanoma; Pancreatic cancer; Solid tumours
  • Focus Adverse reactions; First in man
  • Sponsors Pasithea Therapeutics

Most Recent Events

  • 30 Jun 2026 According to Pasithea Therapeutics media release, the final PFS data will not be known until the end of the trial. The Company plans to submit and present a more robust data set at a future scientific conference.
  • 30 Jun 2026 According to Pasithea Therapeutics media release, the company has decided to extend dose escalation using tablet formulation to explore 18mg, 24mg, 30mg, 40mg, and up to 52mg dose levels to further characterize safety, pharmacokinetics (PK), and early efficacy signals at higher doses. An optional pilot food effect assessment has been introduced to evaluate the impact of fed vs. fasted administration on PAS-004 pharmacokinetics, to optimize long-term dosing strategy.
  • 30 Jun 2026 Interim results presented in the Pasithea Therapeutics Media Release.

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