Actively Recruiting
A Phase 1 Open-label Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAS-004, a MEK 1/2 Inhibitor, in Patients With MAPK Pathway-driven Advanced Solid Tumors With RAS, NF1, or RAF Mutations or Prior BRAF/MEK Inhibition Failure
Led by Pasithea Therapeutics Corp. · Updated on 2025-12-03
48
Participants Needed
7
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating PAS-004, a MEK 1/2 inhibitor, in adults with advanced solid tumors driven by mutations in rat sarcoma virus (RAS), neurofibromatosis type I (NF1), or rapidly accelerated fibrosarcoma (RAF). The study focuses on how well participants tolerate different doses of PAS-004 and the side effects it may cause. This Phase 1 trial is led by Pasithea Therapeutics Corp. and involves patients with tumors that cannot be surgically removed and who have no effective treatment options left. Participants will take PAS-004 orally once daily in 28-day cycles, starting with a single dose followed by a week of observation. The study uses sequential dose escalation from 2 mg up to 45 mg in capsule form, with a separate group receiving 4 mg tablets. Participants may continue treatment for up to two years or until withdrawal, unacceptable side effects, disease progression, other illnesses interfere, or the study ends. During the study, participants will have regular visits to the doctor for tests, exams, and blood work to monitor safety, drug levels in the blood, and effects on tumors. Key outcomes include dose limiting toxicities, adverse events, pharmacokinetics, tumor response, progression-free survival, and overall survival. Safety follow-up continues for 30 days after stopping the drug, and participants’ health is closely observed throughout the trial period.
CONDITIONS
Brief Title
PAS-004 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give signed informed consent
- Informed about study details and risks, and provided written consent
- At least 18 years old at consent
- Able to swallow oral medication
- Diagnosed with MAPK pathway-driven advanced solid tumors that cannot be surgically removed
- Failed or ineligible for standard treatments and have no available options with known benefit
- Documented RAS, NF1, or RAF mutations; RAF mutation patients must have failed prior BRAF/MEK inhibition
- Agree to provide tumor tissue sample if no prior genetic test result is available
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Estimated life expectancy of at least 12 weeks
- Adequate organ function with specified lab value ranges
- Agree to use effective contraception or abstain during and for 90 days after treatment; male patients agree not to donate sperm during this time
You will not qualify if you...
- Participation in another therapeutic clinical trial within 3 weeks
- Received chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy, or other antitumor treatment within 21 days or five half-lives before enrollment
- Known or active central nervous system metastases, except certain stable brain metastases after discussion
- Unresolved toxicity from prior antitumor therapy above Grade 2 except alopecia; neurotoxicity restored to Grade 2 or below; recent severe bleeding
- Use of strong CYP3A inhibitors or inducers within 14 days before dosing
- Use of QTc prolonging medications within 7 days or longer if needed before dosing
- Active swallowing difficulties or conditions affecting drug absorption
- Previous or current retinal vein stenosis, retinal detachment, central retinal vein occlusion, or active glaucoma
- Active interstitial pneumonia or significant radiation pneumonitis
- Impaired heart function or significant arrhythmias as specified
- Pregnant or breastfeeding females
- Known allergy or severe reaction to PAS-004 or its components
- Active bacterial, fungal, or viral infections including certain hepatitis or HIV infections
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 35 days (Cycle 1)
Participants receive oral PAS-004 capsules or tablets once daily in escalating doses to assess safety, tolerability, and pharmacokinetics.
Multiple visits during Cycle 1 including Day 1, 4, 8, 15, 22, 29, and 35 for assessments and dosing
Duration - 30 days after discontinuation of study drug
Participants are monitored for safety and adverse events for 30 days after stopping the study drug.
Follow-up visits during the 30-day post-treatment period
Trial Site Locations
Total: 7 locations
1
NEXT Oncology
Austin, Texas, United States, 78758
Active, Not Recruiting
2
NEXT Oncology
Irving, Texas, United States, 75039
Active, Not Recruiting
3
NEXT Oncology
San Antonio, Texas, United States, 78229
Active, Not Recruiting
4
NEXT Oncology
Fairfax, Virginia, United States, 22031
Active, Not Recruiting
5
MBAL Sveta Sofia
Sofia, Bulgaria, 1404
Actively Recruiting
6
Institute of Oncology Bucharest Prof. Dr. Alexandru Trestioreanu
Bucharest, Romania, 022328
Actively Recruiting
7
Institute of Oncology Prof. Dr. Ion Chiricuta
Cluj-Napoca, Romania, RO-400015
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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