RAS MutationPhase 1NCT06299839
PAS-004 in Patients With Advanced Solid Tumors
A Phase 1 study testing PAS-004 Capsules and PAS-004 Tablets in people with RAS Mutation and NF1 Mutation, run by Pasithea Therapeutics Corp. at 7 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RAS Mutation, NF1 Mutation, RAF Mutation
- What is being tested?
- PAS-004 Capsules and PAS-004 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 29 Feb 2024to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Capable of giving signed informed consent which includes compliance with the requirements, prohibitions and restrictions listed in the informed consent form (ICF).
- Patient has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits, the potential risks, and the discomfort to which they may be exposed and has given written consent to participation in the study prior to study start and any study-related procedure.
- Patient must be at least 18 years of age at the time of signing the ICF.
- Patient must be able to swallow oral medication.
- Patient with histologically or cytologically diagnosed mitogen-activated protein kinase (MAPK) pathway driven advanced solid tumors with all of the following characteristics:
- Tumor cannot be surgically resected
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- Patient has failed or is ineligible for standard of care therapy
- Patient has no available treatment options with known clinical benefit
- Documented evidence of rat sarcoma virus (RAS), neurofibromatosis type I (NF1), and/or rapidly accelerated fibrosarcoma (RAF) mutations. Patients with RAF mutations must have previously failed v-Raf murine sarcoma viral oncogene homolog B (BRAF) / MEK inhibition.
- Prior to enrollment, patients without an existing prior genetic test result or adequate tumor tissue sample must agree to provide tumor tissue via biopsy (paraffin section or fresh tissue specimens) that will be sent for analysis to confirm eligibility.
- Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (Appendix B).
- Patient must have an estimated life expectancy of at least 12 weeks in the opinion of the Investigator at the time of informed consent.
- Patient must have adequate organ function at screening as indicated by the following laboratory value ranges:
- Serum total bilirubin ≤ 1.5 × upper limit normal (ULN) (Serum total bilirubin can be ≤ 3.0 × ULN if patients have hemolysis or congenital hemolytic diseases)
- Aspartate aminotransferase (AST) ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases
- Alanine aminotransferase (ALT) ≤ 2.5 × ULN or 5 × ULN for patient with liver metastases
- Albumin ≥2 mg/dL
- Creatinine clearance ≥ 45 mL/min (as calculated per Cockcroft-Gault)
- Absolute neutrophil count (ANC) ≥ 1.5×109/L
- Platelets ≥ 100×109/L
- Hemoglobin ≥ 90 g/L (Note: Criteria must be met without a transfusion within 2 weeks of obtaining the sample)
- Patient must agree to maintain abstinence (no heterosexual intercourse) or use a highly effective form of contraception during study treatment and for at least 90 days after the last dose of IP. Male patients must agree not to donate sperm while receiving IP and for at least 90 days after the last dose of IP.
Who cannot join
- Participation in another therapeutic clinical trial within 3 weeks of enrollment.
- Having received chemotherapy, radiotherapy, major surgery, targeted therapy, immunotherapy, or other antitumor treatment within 21 days of enrollment or five half-lives of the administered therapy, whichever occurs first.
- Known or active central nervous system metastases.
- Patients with untreated brain metastases ≤ 30 mm that are asymptomatic, do not have significant edema, and do not require steroids or anti-seizure medications are eligible after discussion with the Medical Monitor.
- Patients with previously treated brain metastases may participate provided they are stable after treatment and without evidence of progression by imaging for at least 4 weeks prior to the first dose of IP administration and are not using corticosteroids for at least 7 days prior to IP administration.
- Patients with confirmed leptomeningeal disease are to be excluded.
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- Unresolved toxicity from prior antitumor therapy defined as AEs \> Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for alopecia; neurotoxicity AEs of patients who have received prior chemotherapy needs to be restored to Grade 2 or below. Patients with ≥ Grade 3 bleeding within 4 weeks of first study treatment dose should be excluded.
- Taken a medication that is a strong cytochrome P450 (CYP3A) inhibitor or inducer within 14 days of initiation of study therapy dosing.
- Taken a known corrected QT (QTc) interval prolongating medication within 7 days of initiation or longer if the half-life of the QTc prolonging medication is such that the drug is not cleared from the body within 7 days (5 half-lives) of initiation of study therapy dosing.
- Active dysphagia, digestive system disease, malabsorption syndrome, or other conditions affecting PAS-004 absorption.
- Previous or current retinal vein stenosis, retinal detachment, central retinal vein occlusion, or currently active glaucoma.
- Active interstitial pneumonia, including clinically significant radiation pneumonitis.
- Impaired cardiac function or cardiac disease as indicated by:
- Average QTc interval \> 470 ms as calculated according to the QTc formula of the instrument at the research center where electrocardiogram (ECG) measurements are performed.
- Grade ≥ 3 congestive heart failure per New York Heart Association (NYHA) guidelines.
- Clinically significant arrhythmias, including but not limited to, complete left bundle branch conduction abnormalities and 2nd degree atrioventricular block.
- Pregnant or lactating female patients.
- Known allergy or hypersensitivity to the investigational product (IP), including excipients, or history of severe adverse reaction to any drug, or sensitivity to components of the IP.
- Clinically active bacterial, fungal, or viral infections, hepatitis B (hepatitis B virus surface antigen positive and hepatitis B virus DNA over 1000 IU/ml) or hepatitis C (hepatitis C virus RNA positive), human immunodeficiency virus infection (HIV positive).
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States4 sites
- Active, not recruiting
NEXT Oncology
Austin, Texas, 78758
- Active, not recruiting
NEXT Oncology
Fairfax, Virginia, 22031
- Active, not recruiting
NEXT Oncology
Irving, Texas, 75039
- Active, not recruiting
NEXT Oncology
San Antonio, Texas, 78229
Romania2 sites, 2 recruiting
- Recruiting
Institute of Oncology Bucharest Prof. Dr. Alexandru Trestioreanu
Bucharest, 022328
Natalia E. Cojocaru, +40-783-225-184, natalia.cojocaru@arensia-em.com
Laurentia Nicoleta Gales
- Recruiting
Institute of Oncology Prof. Dr. Ion Chiricuta
Cluj-Napoca, RO-400015
Adriana Badau, +40-786-042-357, adriana.badau@arensia-em.com
Tudor Eliade Ciuleanu
Bulgaria1 site, 1 recruiting
- Recruiting
MBAL Sveta Sofia
Sofia, 1404
Veronika Shopova, +359-878-33-4932, veronika.shopova@arensia-em.com
Marchela Koleva
About this study
Official title: 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 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.
Read more
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.
- Conditions
- RAS Mutation, NF1 Mutation, RAF Mutation, Advanced Solid Tumors
- Being tested
- PAS-004 Capsules, PAS-004 Tablets
- Keywords
- Cancer, malignant neoplasms, Advanced Solid Tumors, MAP Kinase Signaling Pathway
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAS-004 CapsulesDrug
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 TabletsDrug
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 group | Role | What they receive |
|---|---|---|
| PAS-004 Capsules | Experimental | Sequential dose escalation: 2 mg, 4 mg, 8 mg, 15 mg, 22 mg, 30 mg, 37 mg, and 45 mg Receives: Drug: PAS-004 Capsules |
| PAS-004 Tablets | Experimental | A single cohort at the 4mg dose using tablet formulation of PAS-004 Receives: Drug: PAS-004 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of dose limiting toxicities (DLTs)
Pre-defined DLTs will be assessed for dose escalation and expansion determinations.
Measured: Day 1 through Day 35 (Cycle 1)
Evaluation of adverse events (AEs)
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).
Measured: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004.
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).
Measured: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
Evaluation of hematology laboratory parameters
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).
Measured: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
Evaluation of clinical chemistry laboratory parameters
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).
Measured: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
Secondary outcomes (12)
Apparent terminal elimination half-life (t1/2) in Plasma
Measured: Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)
Peak Plasma Concentration (Cmax)
Measured: Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)
Plasma predose or trough concentration (Ctau/Ctrough)
Measured: Cycle 1: Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 8, 15, 29 and 35 (predose)
Time of maximum plasma concentration (Tmax)
Measured: Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)
Area under the concentration versus time curve from time zero to the last sampling time with quantifiable analyte (AUC0-t)
Measured: Cycle 1: Day 1 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4
Area under the concentration versus time curve from time zero extrapolated to infinity if possible (AUC0-∞)
Measured: Cycle 1: Day 1 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4
Area under the concentration versus time curve for the dosing interval, assuming steady state has been reached and duplicating the predose concentration for the 24 hour postdose concentration (AUC0-tau)
Measured: Cycle 1: Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 8, 15, 29 and 35 (predose)
Apparent total plasma clearance if possible (CL/F)
Measured: Cycle 1: Day 1 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, and 8 (predose)
Evaluation of the percentage of extracellular signal-regulated kinase phosphorylation (pERK) inhibition from baseline
Measured: Day 1 through Day 35 (Cycle 1)
Evaluation of the objective response rate (ORR)
The proportion of participants achieving a partial response (PR) or complete response (CR) per response evaluation criteria in solid tumors (RECIST) 1.1 criteria.
Measured: Screening, Day 35 (Cycle 1), and every 9 weeks thereafter
Evaluation of progression-free survival (PFS)
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).
Measured: Cycle 1 Day 1 to date of death, up to 25 months from last participant enrolled
Evaluation of overall survival (OS)
The time from first dose of IP to the date of death due to any cause.
Measured: Cycle 1 Day 1 to date of death, up to 13 months from last participant enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start29 Feb 2024
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS MutationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3+3 dose expansion
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pasithea Therapeutics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tiago R Marques, MD, Study director, Pasithea Therapeutics Corp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299839
- Sponsor's protocol ID
- PAS-004-102
- Other IDs
- 2024-510900-34
- Status last verified
- Nov 2025
- First submitted
- 12 Feb 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06299839
- Acronym / sponsor ID
- PAS-004-102
- Conditions
- RAS Mutation, NF1 Mutation, RAF Mutation, Advanced Solid Tumors
- Keywords
- Cancer, malignant neoplasms, Advanced Solid Tumors, MAP Kinase Signaling Pathway
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pasithea Therapeutics Corp.Industry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 3+3 dose expansion
| Arm | Type | Receives |
|---|---|---|
| PAS-004 Capsules | Experimental | Drug: PAS-004 CapsulesSequential dose escalation: 2 mg, 4 mg, 8 mg, 15 mg, 22 mg, 30 mg, 37 mg, and 45 mg |
| PAS-004 Tablets | Experimental | Drug: PAS-004 TabletsA single cohort at the 4mg dose using tablet formulation of PAS-004 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Capable of giving signed informed consent which includes compliance with the requirements, prohibitions and restrictions listed in the informed consent form (ICF).
- Patient has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits, the potential risks, and the discomfort to which they may be exposed and has given written consent to participation in the study prior to study start and any study-related procedure.
- Patient must be at least 18 years of age at the time of signing the ICF.
- Patient must be able to swallow oral medication.
- Patient with histologically or cytologically diagnosed mitogen-activated protein kinase (MAPK) pathway driven advanced solid tumors with all of the following characteristics:
Key exclusion criteria (19 listed)
- Participation in another therapeutic clinical trial within 3 weeks of enrollment.
- Having received chemotherapy, radiotherapy, major surgery, targeted therapy, immunotherapy, or other antitumor treatment within 21 days of enrollment or five half-lives of the administered therapy, whichever occurs first.
- Known or active central nervous system metastases.
- Unresolved toxicity from prior antitumor therapy defined as AEs \> Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, except for alopecia; neurotoxicity AEs of patients who have received prior chemotherapy needs to be restored to Grade 2 or below. Patients with ≥ Grade 3 bleeding within 4 weeks of first study treatment dose should be excluded.
- Taken a medication that is a strong cytochrome P450 (CYP3A) inhibitor or inducer within 14 days of initiation of study therapy dosing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAS-004 CapsulesA 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. | Drug | PAS-004 Capsules |
| PAS-004 TabletsA 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. | Drug | PAS-004 Tablets |
Primary outcome
Evaluation of dose limiting toxicities (DLTs)
Time frame: Day 1 through Day 35 (Cycle 1)
Pre-defined DLTs will be assessed for dose escalation and expansion determinations.
Evaluation of adverse events (AEs)
Time frame: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
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).
Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004.
Time frame: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
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).
Evaluation of hematology laboratory parameters
Time frame: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
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).
Evaluation of clinical chemistry laboratory parameters
Time frame: Screening through Day 1 through Day 35 (Cycle 1), and 30 days after discontinuation of study drug
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).
12 secondary outcomes
Apparent terminal elimination half-life (t1/2) in Plasma
Time frame: Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)
Peak Plasma Concentration (Cmax)
Time frame: Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)
Plasma predose or trough concentration (Ctau/Ctrough)
Time frame: Cycle 1: Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 8, 15, 29 and 35 (predose)
Time of maximum plasma concentration (Tmax)
Time frame: Cycle 1: Day 1 and Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, 8, 15, 29 and 35 (predose)
Area under the concentration versus time curve from time zero to the last sampling time with quantifiable analyte (AUC0-t)
Time frame: Cycle 1: Day 1 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4
Area under the concentration versus time curve from time zero extrapolated to infinity if possible (AUC0-∞)
Time frame: Cycle 1: Day 1 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4
Area under the concentration versus time curve for the dosing interval, assuming steady state has been reached and duplicating the predose concentration for the 24 hour postdose concentration (AUC0-tau)
Time frame: Cycle 1: Day 22 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 8, 15, 29 and 35 (predose)
Apparent total plasma clearance if possible (CL/F)
Time frame: Cycle 1: Day 1 (predose, and 30 min, 1 hr, 2 hr, 3 hr, 5 hr, 8 hr and 24 hr post-dose), Day 4, and 8 (predose)
Evaluation of the percentage of extracellular signal-regulated kinase phosphorylation (pERK) inhibition from baseline
Time frame: Day 1 through Day 35 (Cycle 1)
Evaluation of the objective response rate (ORR)
Time frame: Screening, Day 35 (Cycle 1), and every 9 weeks thereafter
Evaluation of progression-free survival (PFS)
Time frame: Cycle 1 Day 1 to date of death, up to 25 months from last participant enrolled
Evaluation of overall survival (OS)
Time frame: Cycle 1 Day 1 to date of death, up to 13 months from last participant enrolled
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institute of Oncology Bucharest Prof. Dr. Alexandru Trestioreanu
Bucharest, Romania
Institute of Oncology Prof. Dr. Ion Chiricuta
Cluj-Napoca, Romania
Tiago R Marques, MD study director
Pasithea Therapeutics Corp.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PAS-004 Capsules and PAS-004 Tablets in people with RAS Mutation and NF1 Mutation, run by Pasithea Therapeutics Corp. at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Romania, Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of dose limiting toxicities (DLTs) (time frame: Day 1 through Day 35 (Cycle 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.