NCT07080619

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
20mo left

Started Sep 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Sep 2025Dec 2027

First Submitted

Initial submission to the registry

July 7, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

July 7, 2025

Last Update Submit

September 4, 2025

Conditions

TNBC - Triple-Negative Breast CancerHR+ Breast Cancer

Keywords

SC-101

Outcome Measures

Primary Outcomes (1)

  • cORR

    Investigator-assessed confirmed objective response rate

    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.

Study Arms (1)

TNBC, HR+HER2- BC, and other tumors

EXPERIMENTAL

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

Drug: SC-101

Interventions

SC-101DRUG

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

TNBC, HR+HER2- BC, and other tumors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Jing Wu Wu

CONTACT

021-33670866wujing@conjustar.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 23, 2025

Study Start

September 20, 2025

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

September 11, 2025

Record last verified: 2025-09