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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)

ConditionTriple-Negative Breast Cancer (TNBC)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-B01D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • PD-1 monoclonal antibody

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Nab-paclitaxel

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

436 Participants
are divided into 2 treatment groups
Group A: BL-B01D1+PD-1 monoclonal antibodyExperimental treatment 2 interventions
Group B: nab-paclitaxel+PD-1 monoclonal antibodyActive comparator 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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