SMP-656 for HER2-Positive Advanced Breast Cancer

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? W

Trial Details

NCT ID
NCT07726342
Phase
PHASE2
Sponsor
Chengdu SciMount Pharmatech Co., Ltd.
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • SMP-656 Injection
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Guangzhou, Guangdong, China|23.11667,113.25
  • Shijiazhuang, Hebei, China|38.04139,114.47861

Key Eligibility Criteria

  • Voluntarily participate in this clinical trial, understand and comply with study procedures, and provide written informed consent voluntarily.
  • Female patients aged ≥ 18 years at the time of signing the informed consent form.
  • Patients with histologically or cytologically confirmed unresectable HER2-positive locally advanced or metastatic breast cancer, regardless of horm…
  • HER2-positive status confirmed by testing at the study center or an accredited laboratory, where HER2 positivity is defined as IHC 3+, or IHC 2+ wi…

For full eligibility, visit ClinicalTrials.gov.

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