SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SC-101.
- Who it may be relevant to
- Registry conditions: TNBC - Triple-Negative Breast Cancer, HR+ Breast Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase IIa Clinical Study to Assess the Efficacy and Safety of SC-101 in Patients With Advanced Malignant Tumors Positive for NECTIN4 Gene Amplification
Overview
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.
Detailed description
The study will include multiple cohorts: triple-negative breast cancer (TNBC), HR-positive HER2-negative breast cancer, and other solid tumors.
Participants will receive SC-101 at a dose of 7.5 mg/m² once weekly, with treatment cycles lasting 28 days. The study aims to assess tumor response and safety until disease progression or other reasons for treatment discontinuation.
Eligibility requires patients to have locally advanced or metastatic tumors that have either relapsed after standard treatment, are resistant to treatment, or are not amenable to standard treatment. NECTIN4 gene amplification must be confirmed via tumor tissue testing.
Imaging assessments will be conducted every 8 weeks to evaluate tumor response. Safety follow-up will be performed 30 days after the last dose, with additional survival follow-ups every 12 weeks thereafter.
Interventions
- Drug SC-101
Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW).
Primary outcome measures
- cORR [Time frame: 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 criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07080619 · SC-101-201