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Trial Title:
A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
NCT ID:
NCT06445400
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Docetaxel
Pertuzumab
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-M07D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
Pertuzumab
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Intervention type:
Drug
Intervention name:
Docetaxel
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Study treatment
Summary:
This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1,
BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients
with unresectable locally advanced or metastatic HER2-positive breast cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Sign the informed consent form voluntarily and follow the protocol requirements;
2. Gender is not limited;
3. Age ≥18 years old and ≤75 years old;
4. Expected survival time for 3 months or more;
5. Patients with histologically and/or cytologically confirmed unresectable locally
advanced or metastatic HER2-positive breast cancer;
6. Consent to provide archived tumor tissue samples or fresh tissue samples from the
primary or metastatic lesions;
7. At least one measurable lesion meeting the RECIST v1.1 definition was required;
8. Physical condition score ECOG 0 or 1 ;
9. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. No blood transfusion, no colony-stimulating factor, and no albumin are allowed
within 14 days before the first use of the study drug, and the organ function level
must meet the requirements;
12. Blood coagulation function: international standardization ratio (INR) 1.5 or less,
and the part activated clotting time (APTT) live enzymes acuities were 1.5 x ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. Fertile female subjects, or male subjects with fertile partners, must use highly
effective contraception from 7 days before the first dose until 7 months after the
end of the dose. Female subjects of childbearing potential had to have a negative
serum pregnancy test within 7 days before the first dose.
Exclusion Criteria:
1. Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the
first dose, received surgery within 4 weeks before the first dose, and received
endocrine therapy within 2 weeks before the first dose;
2. Patients with locally advanced or metastatic disease who have received previous
systemic therapy;
3. Had received prior ADC drug therapy with camptothecin derivative as toxin;
4. Screening within the first half of the serious heart, cerebrovascular disease;
5. Complicated with pulmonary diseases leading to severe impairment of lung function;
6. A history of ILD/interstitial pneumonia requiring steroid therapy, current
ILD/interstitial pneumonia, or suspected ILD;
7. QT prolongation, complete left bundle branch block, III degree atrioventricular
block, frequent and uncontrollable arrhythmia;
8. Other primary malignancies diagnosed within 5 years before the first dose;
9. Poorly controlled hypertension;
10. Patients with active central nervous system metastases;
11. Need treatment intervention of unstable thrombotic events, except infusion related
thrombosis;
12. Patients with a history of allergy to recombinant humanized antibodies or to any
excipients of the trial drug;
13. Had received more than the following cumulative doses of anthracyclines;
14. Systemic corticosteroids or immunosuppressive agents were required within 2 weeks
before study dosing;
15. Patients with massive or symptomatic effusions or poorly controlled effusions;
16. Severe systemic infection within 4 weeks before screening;
17. Active autoimmune and inflammatory diseases;
18. Human immunodeficiency virus antibody positive, active hepatitis B virus infection
or hepatitis C virus infection;
19. Previous history of allogeneic stem cell, bone marrow or organ transplantation;
20. A history of severe neurological or psychiatric illness;
21. Pregnancy or lactation women;
22. Patients who were deemed by the investigator to be ineligible for participation in
the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Herui Yao
Investigator:
Last name:
Herui Yao
Email:
Principal Investigator
Investigator:
Last name:
Qiang Liu
Email:
Principal Investigator
Start date:
June 19, 2024
Completion date:
June 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/NCT06445400
