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)

Official record

Identifier

NCT07729956

Recruiting locations

country

China

Interventions studied

BL-B01D1PD-1 monoclonal antibodyNab-paclitaxel

Lead sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Target enrolment

436 participants

Study type

INTERVENTIONAL

Phase

Phase 3

Status

Recruiting

First posted

Jul 28, 2026

Last updated on the registry

Sep 30, 2026

Age

18 Years – 75 Years

Sex

FEMALE

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Breast Cancer