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Trial Title:
A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer
NCT ID:
NCT06471205
Condition:
Triple-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Antibodies
Antibodies, Monoclonal
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1
Description:
Administration by intravenous infusion on D1 and D8, or D1 for a cycle of 3 weeks.
Arm group label:
BL-B01D1+PD-1 Monoclonal Antibody
Intervention type:
Drug
Intervention name:
PD-1 Monoclonal Antibody
Description:
Administration by intravenous infusion for a cycle of 3 weeks (Q3W).
Arm group label:
BL-B01D1+PD-1 Monoclonal Antibody
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. Age: ≥18 years old and ≤75 years old;
3. Expected survival time ≥3 months;
4. ECOG 0 or 1;
5. Subjects with histologically and/or cytologically confirmed, inoperable locally
advanced or recurrent or metastatic triple-negative breast cancer;
6. Patients should not have received previous systemic therapy for unresectable,
locally advanced, recurrent, or metastatic triple-negative breast cancer;
7. A archived tumor tissue specimen or fresh tissue specimen of the primary or
metastatic lesion within 2 years must be provided;
8. Must have at least one place in accordance with RECIST v1.1 define measurable
lesions;
9. 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;
10. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by
NCI-CTCAE v5.0;
11. 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:
1. ADC drugs that have received topoisomerase I inhibitors as small molecule toxins;
2. Palliative radiotherapy within 2 weeks before the first dose;
3. Patients with checkpoint inhibitors prior to neoadjuvant/adjuvant chemotherapy;
4. Use of an immunomodulatory drug within 14 days before the first dose of study drug;
5. The history of severe cardiovascular and cerebrovascular diseases in the past six
months was screened;
6. QT prolongation, complete left bundle branch block, III degree atrioventricular
block, frequent and uncontrollable arrhythmia;
7. Active autoimmune and inflammatory diseases;
8. Receiving long-term systemic corticosteroid therapy, etc., before the first dose;
9. Other malignant tumors that progressed or required treatment within 5 years before
the first dose;
10. 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;
11. Present grade ≥2 radiation pneumonitis according to the RTOG/EORTC definition;
Patients with current ILD;
12. Complicated with pulmonary diseases leading to clinically severe respiratory
impairment;
13. 6 months prior to screening needs treatment intervention unstable thrombotic events;
14. Patients with active central nervous system metastases;
15. Patients with massive or symptomatic effusions or poorly controlled effusions;
16. Allergic history to recombinant humanized antibody or human-mouse chimeric antibody
or allergic to any excipients of the test drug;
17. Prior organ transplantation or allogeneic hematopoietic stem cell transplantation;
18. HIV antibody positive, active tuberculosis, active hepatitis B virus infection, or
active hepatitis C virus infection;
19. Serious infection within 4 weeks before the first dose of study drug; Signs of
pulmonary infection or active pulmonary inflammation within 4 weeks;
20. Participated in another clinical trial within 4 weeks before the first dose;
21. Patients with superior vena cava syndrome should not be rehydrated;
22. Have a history of psychotropic substance abuse with an inability to quit or a
history of severe neurological or psychiatric illness;
23. Imaging examination showed that the tumor had invaded or wrapped the large thoracic
vessels;
24. Serious unhealed wound, ulcer, or fracture within 4 weeks before signing the
informed consent;
25. Clinically significant bleeding or obvious bleeding tendency within 4 weeks before
signing the informed consent;
26. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28
days before the first dose;
27. Other circumstances considered by the investigator to be inappropriate for
participation in the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiong Wu
Investigator:
Last name:
Jiong Wu
Email:
Principal Investigator
Investigator:
Last name:
Jian Zhang
Email:
Principal Investigator
Start date:
August 2, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06471205
