HR+ Breast Cancer, TNBC - Triple-Negative Breast Cancer
Conditions
Keywords
SC-101
Brief 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.
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
DRUGSC-101
Receive 7.5 mg/m² of SC-101 intravenously once weekly (QW).
Sponsors
Tianjin ConjuStar Biologics Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Contacts
Primary ContactJing Wu Wu
Outcome results
None listed