Trials / Recruiting
RecruitingNCT07182721
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
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-09-30
- Primary completion
- 2028-09-30
- Completion
- 2029-02-01
- First posted
- 2025-09-19
- Last updated
- 2025-09-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07182721. Inclusion in this directory is not an endorsement.