nctId: NCT06334432 id: NUV-1511-01 briefTitle: Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors overallStatus: RECRUITING date: 2024-03 date: 2027-03 date: 2027-10 date: 2024-03-28 date: 2024-03-28 name: Nuvation Bio Inc. class: INDUSTRY 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. 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) studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 allocation: NON_RANDOMIZED interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 466 type: ESTIMATED name: NUV-1511 measure: Phase 1: Assess safety and tolerability of NUV-1511 in advanced solid tumors measure: Phase 1: Identify recommended dosing schedule(s) and corresponding Phase 2 dose(s) (RP2D(s)) measure: Phase 2: Evaluate the efficacy of NUV-1511 in advanced solid tumors and selected tumor type(s) measure: Phase 2: Confirm the optimal NUV-1511 dose level/schedule for further development measure: Phase 2: Confirm the optimal NUV-1511 target tumor types for further development measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Phase 1: Explore preliminary efficacy of NUV-1511 measure: Characterize the PK profile of NUV-1511 measure: Characterize the PK profile of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 2: Further evaluate the safety and efficacy of NUV-1511 measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity via ctDNA and tumor tissue analysis measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Evaluate biomarkers potentially related to NUV-1511 anti-tumor activity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Phase 1 and Phase 2: Explore pharmacogenetic profiling that may be potentially predictive of NUV-1511 antitumor activity or toxicity measure: Evaluate drug exposure-response relationship measure: Evaluate drug exposure-response relationship sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: NEXT Oncology status: RECRUITING city: Irving state: Texas zip: 75038 country: United States name: Naga Koteswari Cheedella role: CONTACT phone: 214-645-4673 email: ncheedella@nextoncology.com lat: 32.81402 lon: -96.94889 facility: START Mountain status: RECRUITING city: Salt Lake City state: Utah zip: 84124 country: United States name: William McKean role: CONTACT phone: 801-581-2121 email: William.McKean@hci.utah.edu lat: 40.76078 lon: -111.89105 facility: NEXT Oncology status: RECRUITING city: Fairfax state: Virginia zip: 22031 country: United States name: Alex Spira role: CONTACT phone: 210-580-9500 email: aspira@nextoncology.com lat: 38.84622 lon: -77.30637 hasResults: False