RecruitingPhase 2NCT07182721

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

A Phase II, Single-Arm, Single-Center, Prospective Study of SKB264 Plus Inetetamab in HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Patients Progressing After T-DXd Treatment


Sponsor

Fudan University

Enrollment

48 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of SKB264 (a new antibody-drug conjugate) with inetetamab (a HER2-targeted antibody) in people with HER2-positive metastatic breast cancer that has already been treated with trastuzumab deruxtecan (T-DXd) and trastuzumab. **You may be eligible if...** - You are 18 or older - You have HER2-positive breast cancer that has spread (metastatic) or cannot be surgically removed - You have previously received both trastuzumab (or a biosimilar) and trastuzumab deruxtecan (T-DXd) for advanced disease - Your cancer is measurable on imaging - You have adequate organ function and a good performance status **You may NOT be eligible if...** - Your cancer is not HER2-positive - You have not received prior T-DXd and trastuzumab - You have active brain metastases, severe lung problems, or serious heart conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB264 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.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT07182721