A Phase I/II Study of XZP-3287 in Metastasis Solid Tumors

StatusUnknown
PhasePhase 1/2
Started

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Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Active, Not Recruiting
  2. Primary completion date changed from estimate of Dec 30, 2021 to Jul 31, 2023v2 Show 9 more changesShow less
    • Primary endpoints revised (2)
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 300 to confirmed 402
    • Study completion date: Dec 30, 2022 to Dec 31, 2025
    • Interventions: XZP-3287 (Drug) to XZP-3287 (Drug), XZP-3287 (Drug), XZP-3287;Letrozole;Anastrozole;Fulvestrant (Drug)
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 6 to 8
    • Site details revised
    • Study arms: 1 to 3
  3. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study includes single agent/combination dose exploration study and the phase II study. The primary purpose of the dose exploration study is to determine the maximum tolerated dose(MTD)/recommended phase II dose(RP2D) of XZP-3287 and assess its safety and preliminary efficacy in solid tumor patients. The phase II study aims to explore the efficacy and safety profiles of XZP-3287 as a single- agent in hormone receptor(HR) positive, human epidermal growth factor receptor 2(HER2) negative advanced breast cancer.
Trial Details
NCT Number NCT04539496
Lead Sponsor Sihuan Pharmaceutical Holdings Group Ltd.
Conditions
(from sponsor)		 Metastasis Solid Tumors, Advanced Breast Cancer
Enrollment 402 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov