SC-101 in Subjects With Advanced NECTIN4-Amplified Cancers

NCT ID: NCT07080619

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-20
• Study Completion Date: 2027-12-30

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TNBC, HR+HER2- BC, and other tumors

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

Group Type: EXPERIMENTAL

SC-101

Intervention Type: DRUG

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

Interventions

SC-101

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin ConjuStar Biologics Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jing Wu Wu

Role: CONTACT

wujing@conjustar.com

021-33670866

Other Identifiers

SC-101-201

Identifier Type: -

Identifier Source: org_study_id