Recruiting

SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers

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.

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ClinicalTrials.gov IDNCT07080619

PhasePHASE2

Enrollment120

SponsorTianjin ConjuStar Biologics Co., Ltd.

Age18 Years – 75 Years

SexALL

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Conditions studied

TNBC - Triple-Negative Breast Cancer, HR+ Breast Cancer

About this study

Interventions

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

Primary outcomes

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.)

Eligibility information

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.

Study locations

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-06.