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

Official title

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

Overview

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.

Interventions

• Drug BL-B01D1
  Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.
• Drug PD-1 Monoclonal Antibody
  Administration by intravenous infusion for a cycle of 3 weeks (Q3W).

Primary outcome measures

• Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
• Recommended Phase II Dose (RP2D) [Time frame: Up to approximately 24 months]

Secondary outcome measures (4)

• Progression-free survival (PFS) [Time frame: Up to approximately 24 months]
• Disease Control Rate (DCR) [Time frame: Up to approximately 24 months]
• Duration of Response (DOR) [Time frame: Up to approximately 24 months]
• Treatment Emergent Adverse Event (TEAE) [Time frame: Up to approximately 24 months]

Eligibility criteria

Inclusion criteria

• 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;
• Subjects with histologically and/or cytologically confirmed, inoperable locally advanced or recurrent or metastatic triple-negative breast cancer;
• Patients should not have received previous systemic therapy for unresectable, locally advanced, recurrent, or metastatic triple-negative breast cancer;
• A archived tumor tissue specimen or fresh tissue specimen of the primary or metastatic lesion within 2 years must be provided;
• Must have at least one place in accordance with RECIST v1.1 define measurable lesions;
• No blood transfusion, no use of cell growth factors and/or platelet raising drugs within 14 days before screening, and the organ function level must meet the requirements;
• Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
• For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before the initiation of treatment, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.

Exclusion criteria

• 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;
• The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
• QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Active autoimmune and inflammatory diseases;
• Receiving long-term systemic corticosteroid therapy, etc., before the first dose;
• Other malignant tumors that progressed or required treatment within 5 years before the first dose;
• Presence of: a) poorly controlled diabetes mellitus before starting study treatment; b) severe complications associated with diabetes mellitus; c) a glycated hemoglobin level of 8% or more; d) hypertension poorly controlled by two antihypertensive drugs; e) history of hypertensive crisis or hypertensive encephalopathy;
• Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition; Patients with current ILD;
• Complicated with pulmonary diseases leading to clinically severe respiratory impairment;
• 6 months prior to screening needs treatment intervention unstable thrombotic events;
• Patients with active central nervous system metastases;
• Patients with massive or symptomatic effusions or poorly controlled effusions;
• Allergic history to recombinant humanized antibody or human-mouse chimeric antibody or allergic to any excipients of the test drug;
• Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
• HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Serious infection within 4 weeks before the first dose of study drug; Signs of pulmonary infection or active pulmonary inflammation within 4 weeks;
• Participated in another clinical trial within 4 weeks before the first dose;
• Patients with superior vena cava syndrome should not be rehydrated;
• Have a history of psychotropic substance abuse with an inability to quit or a history of severe neurological or psychiatric illness;
• Imaging examination showed that the tumor had invaded or wrapped the large thoracic vessels;
• Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the informed consent;
• Clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
• Subjects who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
• Other circumstances considered by the investigator to be inappropriate for participation in the trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Fudan University Shanghai Cancer Center — Shanghai

Identifiers

NCT: NCT06471205 · BL-B01D1-204-04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗