A Randomized, Open-Label, Multicenter Phase 3 Study of SKB264 Versus Investigator's Choice Chemotherapy as First-Line Treatment in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

SKB264-Ⅲ-11

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

2024-02-01

2026-07-01

2026-07-01

Not yet recruiting

Early phase I

524

Key Inclusion Criteria: 1. Histologically and/or cytologically confirmed TNBC. 2. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent. 3. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease. 4. Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease. 5. At least one measurable lesion per RECIST v1.1. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization. 7. A life expectancy of at least 3 months. 8. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator. 9. Adequate organ and bone marrow function. Key Exclusion Criteria: 1. Active second malignancy. 2. Uncontrolled or clinical significant cardiovascular disease. 3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. 4. Active infection requiring systemic therapy within 2 weeks of randomization. 5. Active hepatitis B or hepatitis C virus infection. 6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 7. Known hypersensitivity to SKB264 or its excipients. 8. Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors. 9. Prior treatment with the same investigator's choice chemotherapy (except taxane). 10. Pregnant or lactating women.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomised in a 1:1 ratio to one of two intervention groups.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 524, 'type': 'ESTIMATED'}}

2024-02-28