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RecruitingPhase 2NCT06471205

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

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

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

52 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Summary

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria11

  • 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 Criteria27

  • 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.

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Interventions

DRUGBL-B01D1

Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.

DRUGPD-1 Monoclonal Antibody

Administration by intravenous infusion for a cycle of 3 weeks (Q3W).

Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT06471205