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Clinical Trials in China / NCT07080619
Recruiting Phase 2

SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers

NCT07080619 · tracked via the Priya Life Science China tracker
Sponsor
Tianjin ConjuStar Biologics Co., Ltd
Phase
Phase 2
Started
2025-08-26
Last updated
2026-10-29

Condition(s) studied

TNBC - Triple-Negative Breast CancerHR+ Breast Cancer

Investigational drug(s) / intervention(s)

SC-101

SC-101: Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW).

Study summary

This study is an open-label, multicenter Phase IIa trial to evaluate the efficacy and safety of SC-101 monotherapy in patients with locally advanced or metastatic malignant tumors who are positive for NECTIN4 gene amplification.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Age between 18 and 75 years (inclusive), regardless of gender. ECOG performance status of 0-1. Expected survival of more than 3 months, as assessed by the investigator. Fertile participants must agree to use contraception. Able to understand the trial requirements and willing and able to comply with the trial and follow-up procedures. Adequate bone marrow and organ function. NECTIN-4 gene amplification positive. Exclusion Criteria: Unstable central nervous system tumors. Adverse reactions from previous anticancer treatments have not recovered to a CTCAE 5.0 grade ≤1. A history of severe cardiovascular or cerebrovascular disease.

Primary outcome measure(s)

  • cORR — Baseline (Day -28 to Day -1); tumor response will be evaluated every 8 weeks (±7 days) from the first dose of study treatment to the data cut-off date, up to 24 months.
    Investigator-assessed confirmed objective response rate

Trial sites (1)

FacilityCityRegionStatus
Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality Recruiting

More Tianjin ConjuStar Biologics Co., Ltd. trials in China

Study SC-101 in Subjects With Advanced Malignancies Recruiting
Study of SC-102 in Patients With Advanced Solid Tumors Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07080619 on ClinicalTrials.gov ↗ ← All trials in China