nctId: NCT06270082 id: IK595-001 briefTitle: Study of IK-595 in RAS- or RAF-altered Advanced Tumors overallStatus: RECRUITING date: 2023-12-18 date: 2027-07 date: 2027-07 date: 2024-02-21 date: 2024-03-12 name: Ikena Oncology class: INDUSTRY 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. 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 studyType: INTERVENTIONAL phases: PHASE1 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 masking: NONE count: 150 type: ESTIMATED name: IK-595 measure: Treatment-emergent adverse events, including treatment-related adverse events, and serious adverse events measure: Dose Limiting Toxicities measure: Treatment-Emergent Adverse Events measure: Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595 measure: Pharmacokinetics of IK-595: half-life (t1/2) measure: Pharmacokinetics of IK-595: Area Under the Curve (AUC) measure: Pharmacokinetics of IK-595: Maximum Plasma Concentration (Cmax) measure: Pharmacokinetics of IK-595: Minimum Plasma Concentration (Cmin) measure: To evaluate pERK fold change from baseline in paired tumor biopsies measure: Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Time to response (TTR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-595 as a single agent measure: Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-595 as a single agent measure: Antitumor activity: Median progression-free survival (PFS) of IK-595 as a single agent measure: Antitumor activity: Median overall survival (OS) of IK-595 as a single agent sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: START Midwest status: RECRUITING city: Grand Rapids state: Michigan zip: 49546 country: United States name: Jacob Goldberg, BA role: CONTACT phone: 616-954-5554 email: jacob.goldberg@startmidwest.com name: Nehal J Lakhani, MD,PhD role: PRINCIPAL_INVESTIGATOR lat: 42.96336 lon: -85.66809 facility: University of Pittsburgh Medical Center- Hillman Cancer Center status: NOT_YET_RECRUITING city: Pittsburgh state: Pennsylvania zip: 15232 country: United States name: Jason Luke, MD role: PRINCIPAL_INVESTIGATOR lat: 40.44062 lon: -79.99589 facility: Sarah Cannon Research Institute status: NOT_YET_RECRUITING city: Nashville state: Tennessee zip: 37203 country: United States name: Meredith McKean, MD role: PRINCIPAL_INVESTIGATOR lat: 36.16589 lon: -86.78444 facility: Next Oncology- San Antonio status: RECRUITING city: San Antonio state: Texas zip: 78229 country: United States name: Carmen Gonzalez role: CONTACT phone: 210-580-9521 email: cgonzalez@nextoncology.com name: Anthony W Tolcher, MD role: PRINCIPAL_INVESTIGATOR lat: 29.42412 lon: -98.49363 facility: Next Oncology- Virginia Cancer Specialists status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Blake Paterson role: CONTACT phone: 703-783-4505 email: mpoole@nextoncology.com name: Alexander Spira, MD role: PRINCIPAL_INVESTIGATOR lat: 38.84622 lon: -77.30637 hasResults: False