MedTrace Logo

SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment

NCT07182721 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.

Conditions

  • HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer
  • SKB264
  • Inetetamab

Interventions

DRUG

SKB264 Plus Inetetamab

SKB264: 5 mg/kg administered on Day 1 of each 2-week cycle. Inetetamab: an initial loading dose of 6 mg/kg is administered, followed by subsequent maintenance doses of 4 mg/kg. Dosing occurs on Day 1 of each 2-week cycle.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Hongxia Wang · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-09-30
Completion
2029-02-01

Countries

  • China

Study Locations

More Related Trials

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 NCT07182721 on ClinicalTrials.gov