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NCT07080619
SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers
Conditions: TNBC - Triple-Negative Breast Cancer, HR+ Breast Cancer
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Tianjin ConjuStar Biologics Co., Ltd.
Location: Fudan University Shanghai Cancer Center Shanghai Shanghai Municipality
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 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.
Source: ClinicalTrials.gov (NCT07080619). StuddyBuddy aggregates publicly available trial information.
