SMP-656 for HER2-Positive Advanced Breast Cancer

StatusRecruiting
PhasePhase 2
Started

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Record History

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  1. Recruitment opened Show 5 more changesShow less
    • Start date changed from estimate of Jul 16, 2026 to Aug 10, 2026
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: details revised at 7 of 15 entries
    • Study description shortened, about 11 words
    • Site details revised at 15 of 15 sites
  2. 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.
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor antibody-drug conjugate (ADC) treatment. It will also evaluate the safety of SMP-656 and identify the optimal dose for future trials. The main questions it aims to answer are: What is the objective tumor response rate (DOR, PFS, DCR, OS) of two different dose regimens of intravenous SMP-656? What are the side effects and safety risks of these two SMP-656 dose regimens? Which dose level achieves the best balance of anti-cancer activity and tolerability? This is a randomized, open-label, dose-optimization Phase II clinical trial. Participants will be randomly assigned 1:1 to receive one of two fixed doses of SMP-656 given intravenously once every 3 weeks. Participants will: Complete screening tests within 28 days before the first SMP-656 infusion to confirm eligibility Receive study treatment every 3 weeks until cancer progression, intolerable side effects, withdrawal, or other stopping criteria Have regular tumor imaging scans, physical exams, vital sign checks, and blood tests to monitor tumor response and safety Attend a safety follow-up visit 30 days after the last dose of SMP-656 Complete longer-term survival follow-up after the 30-day safety check Provide optional blood and tumor tissue samples for additional research studies
Trial Details
NCT Number NCT07726342
Lead Sponsor Chengdu SciMount Pharmatech Co., Ltd.
Conditions
(from sponsor)		 HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
Related terms Breast Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov