Pasithea Therapeutics’ Promising Phase 1 Study on PAS-004 for Advanced Solid Tumors

Pasithea Therapeutics Corp. ((KTTA)) announced an update on their ongoing clinical study.

Pasithea Therapeutics Corp. is conducting a Phase 1 clinical trial titled 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. The study aims to evaluate the safety and side effects of PAS-004 in patients with specific genetic mutations linked to advanced solid tumors.

The intervention being tested is PAS-004, a MEK 1/2 inhibitor, administered orally in capsule and tablet forms. The treatment is designed to target and inhibit specific pathways in cancer cells, potentially offering a new therapeutic option for patients with these mutations.

This interventional study is non-randomized and follows a sequential model with no masking. It uses a 3+3 dose expansion design to determine the optimal dosage for treatment, with the primary purpose being treatment evaluation.

The study began on February 12, 2024, with the last update submitted on August 15, 2025. These dates mark the study’s progress and ongoing recruitment status, which is crucial for tracking its development and potential outcomes.

For investors, the progress of this study could influence Pasithea Therapeutics’ stock performance, as successful results may enhance the company’s market position. The study’s focus on a novel treatment approach may also affect investor sentiment positively, especially in comparison to competitors in the oncology sector.

The study is currently recruiting, and further details are available on the ClinicalTrials portal.