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RecruitingNCT07729956Updated Sep 30, 2026

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)

A Phase 3 interventional study of BL-B01D1 and PD-1 monoclonal antibody in Triple-Negative Breast Cancer (TNBC), sponsored by Sichuan Baili Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Sichuan Baili Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
436
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Triple-Negative Breast Cancer (TNBC)
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
436 participants (estimated)

Study arms

  • Experimental
    BL-B01D1+PD-1 monoclonal antibody

    Participants receive BL-B01D1+PD-1 monoclonal antibody in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

    Drug: BL-B01D1 · Drug: PD-1 monoclonal antibody

  • Active comparator
    nab-paclitaxel+PD-1 monoclonal antibody

    Participants receive nab-paclitaxel+PD-1 monoclonal antibody in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

    Drug: PD-1 monoclonal antibody · Drug: Nab-paclitaxel

Interventions

  • DrugBL-B01D1

    Administration by intravenous infusion for a cycle of 3 weeks.

    Also known as: iza-bren, izalontamab brengitecan, BMS-986507

  • DrugPD-1 monoclonal antibody

    Administration by intravenous infusion for a cycle of 3 weeks.

  • DrugNab-paclitaxel

    Administration by intravenous infusion for a cycle of 3 weeks.

05

What researchers measure

Primary outcomes

  1. BICR-assessed Progression-free Survival (PFS)

    Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

    Time frame: Up to approximately 24 months

Secondary outcomes

  1. Overall Survival (OS)

    Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.

    Time frame: Up to approximately 24 months

  2. Investigator-assessed Progression-free Survival (PFS)

    Investigator-assessed progression-free survival (PFS) per RECIST v1.1 is defined as the time from treatment initiation until the first documented disease progression according to RECIST v1.1 criteria, or death from any cause, whichever occurs first, as determined by the local treating investigator.

    Time frame: Up to approximately 24 months

  3. Objective Response Rate (ORR)

    Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

    Time frame: Up to approximately 24 months

  4. Disease Control Rate (DCR)

    Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

    Time frame: Up to approximately 24 months

  5. Duration of Response (DOR)

    Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

    Time frame: Up to approximately 24 months

  6. Time to Response (TTR)

    Time to Response (TTR) is defined as the time from randomization to the first documented response (CR or PR) according to RECIST v1.1 criteria.

    Time frame: Up to approximately 24 months

  7. Treatment Emergent Adverse Event (TEAE)

    TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-B01D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-B01D1.

    Time frame: Up to approximately 24 months

  8. Cmax

    Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.

    Time frame: Up to approximately 24 months

  9. Tmax

    Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.

    Time frame: Up to approximately 24 months

  10. T1/2

    Half-life (T1/2) of BL-B01D1 will be investigated.

    Time frame: Up to approximately 24 months

  11. AUC0-t

    AUC0-t is defined as area under the serum concentration-time curve from time 0 to the time of the last measurable concentration.

    Time frame: Up to approximately 24 months

  12. CL (Clearance)

    CL in the serum of BL-B01D1 per unit of time will be investigated.

    Time frame: Up to approximately 24 months

  13. Ctrough

    Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.

    Time frame: Up to approximately 24 months

  14. Anti-drug Antibody (ADA)

    Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.

    Time frame: Up to approximately 24 months

  15. Neutralizing Antibody(NAb)

    Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated.

    Time frame: Up to approximately 24 months

06

Study locations

1 of 1 sites recruiting
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    • Jiong Wu · Contact
    • Jiong Wu · Principal investigator
    • Jian Zhang · Principal investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT07729956
Lead sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborators
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Jul 28, 2026
Start date
Sep 2, 2026
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 30, 2026

Study contacts

Sa Xiao, PHD
Contact
xiaosa@baili-pharm.com
+8615013238943

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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