protocolSection identificationModule nctId: NCT06270082, orgStudyIdInfo id: IK595-001, briefTitle: Study of IK-595 in RAS- or RAF-altered Advanced Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-12-18, primaryCompletionDateStruct date: 2027-07, completionDateStruct date: 2027-07, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Ikena Oncology, class: INDUSTRY, descriptionModule briefSummary: This is a Phase 1, FIH, Dose Escalation and Dose Expansion study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) effects, and preliminary antitumor activity of IK-595, a MEK/RAF molecular glue, administered orally as monotherapy in patients with advanced solid tumors with gene alterations in the RAS- MAPK pathway for whom there are no further treatment options known to confer clinical benefit., conditionsModule conditions: Solid Tumor, Adult, conditions: Colorectal Cancer, conditions: Pancreatic Cancer, conditions: Malignant Melanoma, conditions: Ras (Kras or Nras) Gene Mutation, conditions: BRAF Gene Mutation, conditions: CRAF Gene Mutation, conditions: Non-Small Cell Lung Carcinoma, conditions: Thyroid Carcinoma, conditions: Gliomas, Malignant, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Dose Escalation: BOIN design Dose Expansion: 4 genetically/molecularly defined cohorts using Simon 2-stage adaptive design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: IK-595, outcomesModule primaryOutcomes measure: Treatment-emergent adverse events, including treatment-related adverse events, and serious adverse events, primaryOutcomes measure: Dose Limiting Toxicities, primaryOutcomes measure: Treatment-Emergent Adverse Events, primaryOutcomes measure: Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595, secondaryOutcomes measure: Pharmacokinetics of IK-595: half-life (t1/2), secondaryOutcomes measure: Pharmacokinetics of IK-595: Area Under the Curve (AUC), secondaryOutcomes measure: Pharmacokinetics of IK-595: Maximum Plasma Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics of IK-595: Minimum Plasma Concentration (Cmin), secondaryOutcomes measure: To evaluate pERK fold change from baseline in paired tumor biopsies, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-595 as a single agent, secondaryOutcomes measure: Antitumor activity: Median progression-free survival (PFS) of IK-595 as a single agent, otherOutcomes measure: Antitumor activity: Median overall survival (OS) of IK-595 as a single agent, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: START Midwest, status: RECRUITING, city: Grand Rapids, state: Michigan, zip: 49546, country: United States, contacts name: Jacob Goldberg, BA, role: CONTACT, phone: 616-954-5554, email: jacob.goldberg@startmidwest.com, contacts name: Nehal J Lakhani, MD,PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.96336, lon: -85.66809, locations facility: University of Pittsburgh Medical Center- Hillman Cancer Center, status: NOT_YET_RECRUITING, city: Pittsburgh, state: Pennsylvania, zip: 15232, country: United States, contacts name: Jason Luke, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Sarah Cannon Research Institute, status: NOT_YET_RECRUITING, city: Nashville, state: Tennessee, zip: 37203, country: United States, contacts name: Meredith McKean, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.16589, lon: -86.78444, locations facility: Next Oncology- San Antonio, 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, contacts name: Anthony W Tolcher, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Next Oncology- Virginia Cancer Specialists, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Blake Paterson, role: CONTACT, phone: 703-783-4505, email: mpoole@nextoncology.com, contacts name: Alexander Spira, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False