OncoMatch/Clinical Trials/NCT07182721
SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
Is NCT07182721 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies SKB264 Plus Inetetamab for her2-positive, unresectable, locally advanced or metastatic breast cancer.
Treatment: SKB264 Plus Inetetamab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+, or ihc 2+ and fish positive)
Disease stage
Metastatic disease required
Unresectable locally advanced or metastatic breast cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab deruxtecan, trastuzumab) — unresectable locally advanced or metastatic disease OR (neo)adjuvant with recurrence/metastasis during or within 12 months
Prior treatment ... must have included ... trastuzumab deruxtecan (T-DXd) and trastuzumab (or a trastuzumab biosimilar). Patients who received T-DXd and trastuzumab (or a biosimilar) in the (neo)adjuvant setting and experienced recurrence or metastasis during or within 12 months of completing therapy are eligible.
Must have received: taxane
prior treatment regimens must have included a taxane
Cannot have received: TROP2 antibody-drug conjugate
Prior treatment with ... any TROP-2 antibody-drug conjugate (ADC)
Cannot have received: other (inetetamab)
Prior treatment with inetetamab
Lab requirements
Blood counts
ANC ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L; Hemoglobin ≥ 90 g/L
Kidney function
Serum creatinine ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min (Cockcroft-Gault)
Liver function
AST and ALT ≤ 3.0 × ULN; TBIL ≤ 1.5 × ULN. For patients with liver metastases, ALT and AST ≤ 5.0 × ULN.
Cardiac function
LVEF ≥ 50%; QTcF < 470 ms for females and < 450 ms for males
Adequate organ and bone marrow function ... see details in criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify