Triple-Negative Breast Cancer (TNBC)Phase 3NCT07729956
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 study testing BL-B01D1, PD-1 monoclonal antibody and Nab-paclitaxel in people with Triple-Negative Breast Cancer (TNBC), run by Sichuan Baili Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- BL-B01D1, PD-1 monoclonal antibody and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 436 participants
- Where
- 1 siteChina
- Study dates
- 2 Sep 2026to Dec 2029
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Other conditions rendering the patient unsuitable per investigator's judgment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jiong Wu
Jiong Wu
About this study
Official title: A Phase III Randomized Controlled Clinical 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)
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.
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- BL-B01D1, PD-1 monoclonal antibody, Nab-paclitaxel
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BL-B01D1Drug
Also called iza-bren, izalontamab brengitecan, BMS-986507
Administration by intravenous infusion for a cycle of 3 weeks.
PD-1 monoclonal antibodyDrug
Administration by intravenous infusion for a cycle of 3 weeks.
Nab-paclitaxelDrug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-B01D1+PD-1 monoclonal antibody | Experimental | 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. Receives: Drug: BL-B01D1; Drug: PD-1 monoclonal antibody |
| nab-paclitaxel+PD-1 monoclonal antibody | Active comparator | 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. Receives: Drug: PD-1 monoclonal antibody; Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 24 months
Secondary outcomes (15)
Overall Survival (OS)
Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death.
Measured: Up to approximately 24 months
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.
Measured: Up to approximately 24 months
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).
Measured: Up to approximately 24 months
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.
Measured: Up to approximately 24 months
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.
Measured: Up to approximately 24 months
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.
Measured: Up to approximately 24 months
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.
Measured: Up to approximately 24 months
Cmax
Maximum serum concentration (Cmax) of BL-B01D1 will be investigated.
Measured: Up to approximately 24 months
Tmax
Time to maximum serum concentration (Tmax) of BL-B01D1 will be investigated.
Measured: Up to approximately 24 months
T1/2
Half-life (T1/2) of BL-B01D1 will be investigated.
Measured: Up to approximately 24 months
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.
Measured: Up to approximately 24 months
CL (Clearance)
CL in the serum of BL-B01D1 per unit of time will be investigated.
Measured: Up to approximately 24 months
Ctrough
Ctrough is defined as the lowest serum concentration of BL-B01D1 prior to the next dose will be administered.
Measured: Up to approximately 24 months
Anti-drug Antibody (ADA)
Frequency of anti-BL-B01D1 antibody (ADA) will be investigated.
Measured: Up to approximately 24 months
Neutralizing Antibody(NAb)
Frequency of anti-BL-B01D1 neutralizing antibodies will be investigated.
Measured: Up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start2 Sep 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 436 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07729956
- Sponsor's protocol ID
- BL-B01D1-325
- Status last verified
- Sep 2026
- First submitted
- 20 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No