A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Express PD-L1 (PANKU-Breast04)
Starting soon · Phase 3
Conditions studied: Triple-Negative Breast Cancer (TNBC)
In brief
This trial is a registrational Phase III, randomized, open-label, multicenter study designed to compare the efficacy and safety of BL-B01D1 in combination with a PD-1 monoclonal antibody versus nab-paclitaxel in combination with a PD-1 monoclonal antibody in patients with PD-L1-positive, previously untreated, inoperable locally advanced or recurrent metastatic triple-negative breast cancer.
Key facts
- Study ID
- NCT07729956
- Run by
- Sichuan Baili Pharmaceutical Co., Ltd.
- People needed
- 436
- Starts
- 2026-08-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
- Female patients aged 18 to 75 years;
- Expected survival time ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- Pathologically confirmed recurrent or metastatic triple-negative breast cancer;
- Confirmed PD-L1 expression positivity by central laboratory testing;
- No prior systemic anti-tumor therapy in the advanced/recurrent or metastatic setting;
- Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;
- Must have at least one measurable lesion as defined by RECIST v1.1;
- Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;
- Organ function levels must meet the protocol-specified requirements;
- Urine protein ≤ 1+ or < 1000 mg/24 h;
- For premenopausal women of childbearing potential, a pregnancy test (serum) must be performed within 7 days before starting treatment, and pregnancy must be ruled out; patients must not be lactating. All enrolled patients (regardless of sex) must use adequate barrier contraception throughout the entire treatment period and for 7 months after the end of treatment.
You may not qualify if…
- Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;
- Prior exposure to ADC drugs with topoisomerase I inhibitor payload;
- Prior treatment with other T-cell receptor-targeting agents (excluding PD-1/PD-L1);
- Use of immunomodulators within 14 days before the first study drug dose;
- History of severe cardiac or cerebrovascular disease;
- Receiving chronic systemic corticosteroids at >10 mg/day prednisone before the first dose;
- Active autoimmune or inflammatory disease;
- Any thrombotic event within 6 months before randomization;
- Prolonged QTc, complete left bundle branch block, or similar;
- Active malignancy diagnosed within 3 years before randomization;
- Hypertension uncontrolled by two antihypertensives;
- Poorly controlled diabetes/hyperglycemia;
- History of steroid-treated ILD/interstitial pneumonitis;
- Concurrent lung disease causing clinically significant respiratory impairment;
- Active CNS metastases;
- Severe infection within 4 weeks before randomization;
- Massive or symptomatic serosal effusion;
- Severe non-healing wound, ulcer, or fracture within 4 weeks before consent;
- Clinically significant bleeding or bleeding tendency within 4 weeks before consent;
- Inflammatory bowel disease, extensive bowel resection, immune enteritis, bowel obstruction, or chronic diarrhea;
- Allergy or contraindication to the study drug;
- History of autologous/allogeneic stem cell transplantation;
- HIV antibody positive, active HBV, or active HCV;
- History of severe neurological or psychiatric illness;
- Received or planning to receive live vaccine within 28 days before randomization;
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China
Full record on ClinicalTrials.gov
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