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NOT YET RECRUITING
NCT07774624
PHASE1/PHASE2

Study of SKB103 in HER2-negative Breast Cancer

Sponsor: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SKB103 in Participants With Locally Advanced, Recurrent, or Metastatic HER2-negative Breast Cancer.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-08-31

Completion Date

2030-12-31

Last Updated

2026-08-19

Healthy Volunteers

No

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.