protocolSection identificationModule nctId: NCT06299839, orgStudyIdInfo id: PAS-004-102, secondaryIdInfos id: 2024-510900-34, type: EUDRACT_NUMBER, briefTitle: PAS-004 in Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-29, primaryCompletionDateStruct date: 2025-12, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Pasithea Therapeutics Corp., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: RAS Mutation, conditions: NF1 Mutation, conditions: RAF Mutation, conditions: Advanced Solid Tumors, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SEQUENTIAL, interventionModelDescription: 3+3 dose expansion, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 42, type: ESTIMATED, armsInterventionsModule interventions name: PAS-004, outcomesModule primaryOutcomes measure: Evaluation of dose limiting toxicities (DLTs), primaryOutcomes measure: Evaluation of adverse events (AEs), primaryOutcomes measure: Evaluation of AEs leading to discontinuation of investigational product (IP), PAS-004., primaryOutcomes measure: Evaluation of hematology laboratory parameters, primaryOutcomes measure: Evaluation of clinical chemistry laboratory parameters, secondaryOutcomes measure: Apparent terminal elimination half-life (t1/2) in Plasma, secondaryOutcomes measure: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Plasma predose or trough concentration (Ctau/Ctrough), secondaryOutcomes measure: Time of maximum plasma concentration (Tmax), secondaryOutcomes measure: Area under the concentration versus time curve from time zero to the last sampling time with quantifiable analyte (AUC0-t), secondaryOutcomes measure: Area under the concentration versus time curve from time zero extrapolated to infinity if possible (AUC0-∞), secondaryOutcomes measure: 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), secondaryOutcomes measure: Apparent total plasma clearance if possible (CL/F), secondaryOutcomes measure: Evaluation of the percentage of extracellular signal-regulated kinase phosphorylation (pERK) inhibition from baseline, secondaryOutcomes measure: Evaluation of the objective response rate (ORR), secondaryOutcomes measure: Evaluation of progression-free survival (PFS), secondaryOutcomes measure: Evaluation of overall survival (OS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Oncology, status: RECRUITING, city: Austin, state: Texas, zip: 78758, country: United States, contacts name: Erica Torres, role: CONTACT, phone: 210-610-5205, email: etorres@nextoncology.com, geoPoint lat: 30.26715, lon: -97.74306, locations facility: NEXT Oncology, status: RECRUITING, city: Irving, state: Texas, zip: 75039, country: United States, contacts name: Erica Torres, role: CONTACT, phone: 210-610-5205, email: etorres@nextoncology.com, geoPoint lat: 32.81402, lon: -96.94889, locations facility: NEXT Oncology, status: RECRUITING, city: San Antonio, state: Texas, zip: 78229, country: United States, contacts name: Carmen Gonzalez, role: CONTACT, phone: 210-580-9521, email: cgonzalez@nextoncology.com, geoPoint lat: 29.42412, lon: -98.49363, locations facility: NEXT Oncology, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Blake Patterson, role: CONTACT, phone: 703-783-4505, email: BPatterson@nextoncology.com, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False