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Study of SKB103 in HER2-negative Breast Cancer

NCT07774624 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-08-19

No results posted yet for this study

Summary

This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer. The study includes a Phase 1 dose escalation stage and a Phase 2 indication expansion stage.

Conditions

Interventions

DRUG

SKB103 monotherapy

SKB103 for injection, administered as monotherapy via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks, Q3W). Treatment continues until radiographic disease progression (PD), intolerable toxicity, participant request for discontinuation, lost to follow-up, or death, whichever occurs first.

Sponsors & Collaborators

  • Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2029-12-31
Completion
2030-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07774624 on ClinicalTrials.gov