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)

NCT07729956 | Not Yet Recruiting Phase 3

• 1 other identifier: BL-B01D1-325
• Study Type: interventional
• Target: 436
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple-Negative Breast Cancer (TNBC)

Outcome Measures

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.

  Up to approximately 24 months

Secondary Outcomes (15)

• Overall Survival (OS)

  Up to approximately 24 months

• Investigator-assessed Progression-free Survival (PFS)

  Up to approximately 24 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Disease Control Rate (DCR)

  Up to approximately 24 months

• Duration of Response (DOR)

  Up to approximately 24 months

Study Arms (2)

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.

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.

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

Interventions

BL-B01D1 DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

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

BL-B01D1+PD-1 monoclonal antibody

PD-1 monoclonal antibody DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

BL-B01D1+PD-1 monoclonal antibody; nab-paclitaxel+PD-1 monoclonal antibody

Nab-paclitaxel DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

nab-paclitaxel+PD-1 monoclonal antibody

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Sichuan Baili Pharmaceutical Co., Ltd.: lead
• Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

spartalizumab; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sa Xiao, PHD

CONTACT

+8615013238943; xiaosa@baili-pharm.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2026
• First Posted: July 28, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Locations

CN (1)