A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This phase II study is a clinical study to explore the efficacy and safety of BL-B01D1 combined with PD-1 monoclonal antibody in patients with unresectable locally advanced or recurrent metastatic triple-negative breast cancer.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent and follow the requirements of the protocol;

Age: ≥18 years old and ≤75 years old;

Expected survival time ≥3 months;

ECOG 0 or 1;

Disqualifiers

ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;

Palliative radiotherapy within 2 weeks before the first dose;

Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy;

Use of an immunomodulatory drug within 14 days before the first dose of study drug;

Trial design

Treatments tested in this trial

  • BL-B01D1
  • PD-1 Monoclonal Antibody

Treatment groups

52 Participants
are divided into 1 treatment group

Sponsors and collaborators

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

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

Collaborator