BL-B01D1 plus PD-1 therapy vs nab-paclitaxel plus PD-1 therapy in untreated PD-L1-positive locally advanced or metastatic TNBC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a registrational, randomized, open-label phase 3 study comparing two PD-1–based regimens in patients with PD-L1-positive, untreated locally advanced or metastatic triple-negative breast cancer. Participants receive either BL-B01D1 plus a PD-1 monoclonal antibody or nab-paclitaxel plus a PD-1 monoclonal antibody. Key eligibility requires female patients 18–75 with ECOG 0–1, measurable disease, adequate organ function, confirmed PD-L1 positivity, and no prior systemic therapy for advanced disease. Tumor tissue samples are needed for central PD-L1 testing and archival specimens. The trial is multicenter with lead sponsor Sichuan Baili Pharmaceutical and collaborators, conducted at least in part at Fudan University Shanghai Cancer Center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the informed consent form and agree to comply with the protocol requirements;
2. Female patients aged 18 to 75 years;
3. Expected survival time ≥ 3 months;
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Pathologically confirmed recurrent or metastatic triple-negative breast cancer;
6. Confirmed PD-L1 expression positivity by central laboratory testing;
7. No prior systemic anti-tumor therapy in the advanced/recurrent or metastatic setting;
8. Agree to provide archived tumor tissue specimens (surgical specimens) or fresh tissue samples from primary or metastatic lesions obtained within 3 years;
9. Must have at least one measurable lesion as defined by RECIST v1.1;
10. Toxicities from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
11. No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;
12. Organ function levels must meet the protocol-specified requirements;
13. Urine protein ≤ 1+ or \< 1000 mg/24 h;
14. 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.

Exclusion Criteria:

1. Received surgery, radical radiotherapy, or immunotherapy within 4 weeks before the first dose;
2. Prior exposure to ADC drugs with topoisomerase I inhibitor payload;
3. Prior treatment with other T-cell receptor-targeting agents (excluding PD-1/PD-L1);
4. Use of immunomodulators within 14 days before the first study drug dose;
5. History of severe cardiac or cerebrovascular disease;
6. Receiving chronic systemic corticosteroids at \>10 mg/day prednisone before the first dose;
7. Active autoimmune or inflammatory disease;
8. Any thrombotic event within 6 months before randomization;
9. Prolonged QTc, complete left bundle branch block, or similar;
10. Active malignancy diagnosed within 3 years before randomization;
11. Hypertension uncontrolled by two antihypertensives;
12. Poorly controlled diabetes/hyperglycemia;
13. History of steroid-treated ILD/interstitial pneumonitis;
14. Concurrent lung disease causing clinically significant respiratory impairment;
15. Active CNS metastases;
16. Severe infection within 4 weeks before randomization;
17. Massive or symptomatic serosal effusion;
18. Severe non-healing wound, ulcer, or fracture within 4 weeks before consent;
19. Clinically significant bleeding or bleeding tendency within 4 weeks before consent;
20. Inflammatory bowel disease, extensive bowel resection, immune enteritis, bowel obstruction, or chronic diarrhea;
21. Allergy or contraindication to the study drug;
22. History of autologous/allogeneic stem cell transplantation;
23. HIV antibody positive, active HBV, or active HCV;
24. History of severe neurological or psychiatric illness;
25. Received or planning to receive live vaccine within 28 days before randomization;
26. Other conditions rendering the patient unsuitable per investigator's judgment.

Where it's running

• Fudan University Shanghai Cancer Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Sa Xiao, PHD
• Email: xiaosa@baili-pharm.com
• Phone: +8615013238943

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.