SC-101 in NECTIN4-amplified cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase IIa trial evaluating SC-101 monotherapy in adults with NECTIN4-amplified locally advanced or metastatic cancers. Participants receive 7.5 mg/m2 of SC-101 once weekly in 28-day cycles, with tumor assessments every 8 weeks and safety follow-up after treatment ends. The study includes cohorts for triple-negative breast cancer, HR-positive/HER2-negative breast cancer, and other solid tumors, with eligibility requiring confirmed NECTIN4 amplification and disease that has progressed or is intolerant to standard therapy. Imaging will monitor response; additional survival data will be collected over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Jing Wu
• Email: wujing@conjustar.com
• Phone: 021-33670866

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.