A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer(PANKU-Breast02)

NCT06382142 | Active Not Recruiting Phase 3

• 1 other identifier: BL-B01D1-307
• Study Type: interventional
• Target: 418
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced or metastatic Triple-Negative breast cancer after taxane failure.

Conditions

Triple-Negative Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival (PFS)

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

  Up to approximately 24 months

• Overall survival (OS)

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

  Up to approximately 24 months

Secondary Outcomes (5)

• 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

• Treatment Emergent Adverse Event (TEAE)

  Up to approximately 24 months

• Anti-drug antibody (ADA)

  Up to approximately 24 months

Study Arms (2)

BL-B01D1

EXPERIMENTAL

Participants receive BL-B01D1 as intravenous infusion for 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

Eribulin or Vinorelbine or Gemcitabine or Capecitabine

EXPERIMENTAL

Participants receive Eribulin or Vinorelbine or Gemcitabine or Capecitabine 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: Eribulin; Drug: Vinorelbine; Drug: Gemcitabine; Drug: Capecitabine

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

Eribulin DRUG

Administration by intravenous bolus for a cycle of 3 weeks.

Eribulin or Vinorelbine or Gemcitabine or Capecitabine

Vinorelbine DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Eribulin or Vinorelbine or Gemcitabine or Capecitabine

Gemcitabine DRUG

Administration by intravenous infusion for a cycle of 3 weeks.

Eribulin or Vinorelbine or Gemcitabine or Capecitabine

Capecitabine DRUG

Oral administration for a cycle of 3 weeks.

Eribulin or Vinorelbine or Gemcitabine or Capecitabine

Eligibility Criteria

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

You may qualify if:

• Voluntarily sign the informed consent and follow the requirements of the protocol;
• No gender limit;
• Age ≥18 years old and ≤75 years old;
• Expected survival time ≥3 months;
• Patients with unresectable, locally advanced or metastatic triple-negative breast cancer;
• Consent to provide archival tumor tissue samples or fresh tissue samples of primary or metastatic lesions within 3 years;
• The subjects had received 1-2 lines of chemotherapy regimens in the locally advanced or metastatic stage, and had been treated with taxanes previously;
• Acceptability of chemotherapy with eribulin, capecitabine, gemcitabine, or vinorelbine, as assessed by the investigator;
• Patients with baseline brain metastases should have received treatment for all brain metastases and be stable;
• Must have at least one measurable lesion that meets the RECIST v1.1 definition;
• ECOG score 0 or 1;
• Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before the first use of the study drug, and the organ function level must meet the requirements;
• Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5×ULN;

You may not qualify if:

• Prior receipt of an ADC with a TOPI inhibitor as a toxin;
• Prior receipt of an ADC or antibody drug targeting EGFR and/or HER3;
• Chemotherapy, biological therapy, immunotherapy, etc. within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy within 5 days, palliative radiotherapy and anti-tumor therapy within 2 weeks;
• Anthracycline equivalent cumulative dose of adriamycin \> 360 mg/m2;
• History of severe cardiovascular or cerebrovascular disease;
• Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Active malignancy diagnosed within 5 years before randomization;
• Hypertension poorly controlled by two antihypertensive drugs;
• Patients with poor blood glucose control before the first dose;
• A history of interstitial lung disease requiring steroid therapy, or current radiation pneumonitis, or a suspicion of such disease;
• Complicated with pulmonary diseases leading to clinically severe respiratory impairment;
• Patients with carcinomatous meningitis (meningeal metastasis) or brain stem metastasis or spinal cord compression;
• Have a history of allergy to recombinant humanized antibodies or any of the ingredients of BL-B01D1;
• A history of autologous or allogeneic stem cell transplantation;

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

eribulin; Vinorelbine; Gemcitabine; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jiong Wu

  Fudan University

  PRINCIPAL INVESTIGATOR

• Jian Zhang

  Fudan University

  PRINCIPAL INVESTIGATOR

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: April 19, 2024
• First Posted: April 24, 2024
• Study Start: June 21, 2024
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)