protocolSection identificationModule nctId: NCT06334432, orgStudyIdInfo id: NUV-1511-01, briefTitle: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Nuvation Bio Inc., class: INDUSTRY, descriptionModule briefSummary: NUV-1511-01 is a first-in human, open- label, Phase 1/2 to evaluate the safety and efficacy of NUV-1511 in patients with advanced solid tumors. The Phase 1 portion include patients with advanced solid tumors and is designed to determine the safety and the tolerability of doses of NUV-1511. In Phase 2, NUV-1511 will be given to determine the efficacy of patients with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, conditions: HER2-negative Breast Cancer, conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC), conditions: Pancreatic Cancer, conditions: Platinum-resistant Ovarian Cancer (PROC), designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 466, type: ESTIMATED, armsInterventionsModule interventions name: NUV-1511, outcomesModule primaryOutcomes measure: Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors, primaryOutcomes measure: Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s)), primaryOutcomes measure: Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s), primaryOutcomes measure: Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development, primaryOutcomes measure: Phase 2: Confirm the optimal NUV-1511 target tumor types for further development, secondaryOutcomes measure: Phase 1: Explore preliminary efficacy of NUV-1511, secondaryOutcomes measure: Phase 1: Explore preliminary efficacy of NUV-1511, secondaryOutcomes measure: Phase 1: Explore preliminary efficacy of NUV-1511, secondaryOutcomes measure: Characterize the PK profile of NUV-1511, secondaryOutcomes measure: Characterize the PK profile of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, secondaryOutcomes measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity, otherOutcomes measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity, otherOutcomes measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity, otherOutcomes measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity, otherOutcomes measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity, otherOutcomes measure: Evaluate drug exposure-response relationship, otherOutcomes measure: Evaluate drug exposure-response relationship, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: NEXT Oncology, status: RECRUITING, city: Irving, state: Texas, zip: 75038, country: United States, contacts name: Naga Koteswari Cheedella, role: CONTACT, phone: 214-645-4673, email: ncheedella@nextoncology.com, geoPoint lat: 32.81402, lon: -96.94889, locations facility: START Mountain, status: RECRUITING, city: Salt Lake City, state: Utah, zip: 84124, country: United States, contacts name: William McKean, role: CONTACT, phone: 801-581-2121, email: William.McKean@hci.utah.edu, geoPoint lat: 40.76078, lon: -111.89105, locations facility: NEXT Oncology, status: RECRUITING, city: Fairfax, state: Virginia, zip: 22031, country: United States, contacts name: Alex Spira, role: CONTACT, phone: 210-580-9500, email: aspira@nextoncology.com, geoPoint lat: 38.84622, lon: -77.30637, hasResults: False