SMP-656 for HER2-Positive Advanced Breast Cancer

Sponsor
Chengdu SciMount Pharmatech Co., Ltd.
Study ID
NCT07726342
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SMP-656 Injection — DRUG
    SMP-656 injection administered via intravenous infusion at a dose of 2.0 mg/kg once every 3 weeks (Q3W). Treatment continues until disease progression, intolerable toxicity, voluntary withdrawal, death, or trial termination.
  • SMP-656 Injection — DRUG
    SMP-656 injection administered via intravenous infusion at a dose of 2.2 mg/kg once every 3 weeks (Q3W). Treatment continues until disease progression, intolerable toxicity, voluntary withdrawal, death, or trial termination.

Study Details

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

Key Dates

First listed
Jul 24, 2026
Start date
Jul 16, 2026
Status verified
Jul 2026
Primary completion
Jul 7, 2027
Completion
Oct 20, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SMP-656 2.0 mg/kg
    SMP-656 2.0 mg/kg Q3W
  • Experimental: SMP-656 2.2 mg/kg
    SMP-656 2.2 mg/kg Q3W

Primary Outcome Measure

Objective Response Rate (ORR) assessed by Independent Review Committee (IRC) [ Time Frame: From the date of first dose to the date of first radiological documentation of disease progression or death, whichever occurs first (up to 24 months) ]

Central Contacts

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