RecruitingPhase 2NCT06445400
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
A Phase II Clinical Trial to Evaluate the Efficacy and Safety 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
Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment
120 participants
Start Date
Jun 19, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria14
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age ≥18 years old and ≤75 years old;
- Expected survival time for 3 months or more;
- Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic HER2-positive breast cancer;
- Consent to provide archived tumor tissue samples or fresh tissue samples from the primary or metastatic lesions;
- At least one measurable lesion meeting the RECIST v1.1 definition was required;
- Physical condition score ECOG 0 or 1 ;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
- 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;
- 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;
- Urinary protein ≤2+ or ≤1000mg/24h;
- 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 Criteria22
- 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;
- Patients with locally advanced or metastatic disease who have received previous systemic therapy;
- Had received prior ADC drug therapy with camptothecin derivative as toxin;
- Screening within the first half of the serious heart, cerebrovascular disease;
- Complicated with pulmonary diseases leading to severe impairment of lung function;
- A history of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia, or suspected ILD;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Other primary malignancies diagnosed within 5 years before the first dose;
- Poorly controlled hypertension;
- Patients with active central nervous system metastases;
- Need treatment intervention of unstable thrombotic events, except infusion related thrombosis;
- Patients with a history of allergy to recombinant humanized antibodies or to any excipients of the trial drug;
- Had received more than the following cumulative doses of anthracyclines;
- Systemic corticosteroids or immunosuppressive agents were required within 2 weeks before study dosing;
- Patients with massive or symptomatic effusions or poorly controlled effusions;
- Severe systemic infection within 4 weeks before screening;
- Active autoimmune and inflammatory diseases;
- Human immunodeficiency virus antibody positive, active hepatitis B virus infection or hepatitis C virus infection;
- Previous history of allogeneic stem cell, bone marrow or organ transplantation;
- A history of severe neurological or psychiatric illness;
- Pregnancy or lactation women;
- Patients who were deemed by the investigator to be ineligible for participation in the study.
Interventions
DRUGDocetaxel
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGBL-M07D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGPertuzumab
Administration by intravenous infusion for a cycle of 3 weeks.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06445400
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