protocolSection identificationModule nctId: NCT06359860, orgStudyIdInfo id: ST-1898-203, briefTitle: A Study of ST-1898 for Unresectable or Metastatic Melanoma, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-07, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Beijing Scitech-Mq Pharmaceuticals Limited, class: INDUSTRY, descriptionModule briefSummary: ST-1898 is a receptor tyrosine kinase (RTK) inhibitor for multi-targets, especially for VEGFR2, c-MET, AXL, PDGFRA, RET, KIT etc. This trial is to evaluate its safety, tolerability, pharmacokinetic, and efficacy in subjects with unresectable or metastatic melanoma.In phase Ib, the primary objectives are to assess the safety and tolerability, and to determine Recommended Phase 2 dose (RP2D) of ST-1898 tablets in subjects with unresectable or metastatic melanoma. Secondary objectives are to assess the plasma concentration of ST-1898 and to evaluate the efficacy.In phase II, the primary objective is to assess the anti-tumor activities of ST-1898 tablets in subjects with unresectable or metastatic melanoma. The secondary objective is to evaluate the safety of ST-1898 tablets., conditionsModule conditions: Unresectable or Metastatic Melanoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: ST-1898 tablets, outcomesModule primaryOutcomes measure: Phase Ib Dose Escalation: The Number and frequency of treatment-related adverse events (AEs) and treatment related serious adverse events (SAEs), primaryOutcomes measure: Phase Ib Dose Escalation: Recommended Phase 2 Dose (RP2D), primaryOutcomes measure: Phase II Expansion: Objective Response Rate (ORR), secondaryOutcomes measure: Phase Ib Dose Escalation: Trough concentration of ST-1898, secondaryOutcomes measure: Phase Ib Dose Escalation: Peak concentration of ST-1898, secondaryOutcomes measure: Phase Ib Dose Escalation: ORR, secondaryOutcomes measure: Phase Ib Dose Escalation: PFS, secondaryOutcomes measure: Phase Ib Dose Escalation: DoR, secondaryOutcomes measure: Phase Ib Dose Escalation: DCR, secondaryOutcomes measure: Phase Ib Dose Escalation: TTP, secondaryOutcomes measure: Phase II Dose Expansion: The Number and frequency of treatment-related adverse events and serious adverse events (SAEs), secondaryOutcomes measure: Phase II Dose Expansion: Trough concentration of ST-1898, secondaryOutcomes measure: Phase II Dose Expansion: Peak concentration of ST-1898, secondaryOutcomes measure: Phase II Dose Expansion: PFS, secondaryOutcomes measure: Phase II Dose Expansion: DoR, secondaryOutcomes measure: Phase II Dose Expansion: DCR, secondaryOutcomes measure: Phase II Dose Expansion: TTP, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Peking University Cancer Hospital & Institute, status: RECRUITING, city: Beijing, zip: 100142, country: China, contacts name: Jun GUO, MD, role: CONTACT, phone: 0086-10-88121122, email: guoj307@126.co, contacts name: Chuanliang CUI, MD, role: CONTACT, phone: 0086-10-88196348, email: 1008ccl@163.com, contacts name: Jun GUO, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False