HER2-positive Breast Cancer
Conditions
Brief 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.
Interventions
DRUGBL-M07D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGPertuzumab
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGDocetaxel
Administration by intravenous infusion for a cycle of 3 weeks.
Sponsors
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Sichuan Baili Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Up to approximately 24 months | ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1. |
| Recommended Phase II Dose (RP2D) | Up to approximately 24 months | The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M07D1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) | Up to approximately 24 months | The PFS is defined as the time from the participant's first dose of BL-M07D1 to the first date of either disease progression or death, whichever occurs first. |
| Disease Control Rate (DCR) | Up to approximately 24 months | The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]). |
| Duration of Response (DOR) | Up to approximately 24 months | The DOR for a responder is defined as the time from the participant's initial objective response to the first date of either disease progression or death, whichever occurs first. |
| Treatment-Emergent Adverse Event (TEAE) | Up to approximately 24 months | TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1. |
Countries
China
Contacts
Primary ContactSa Xiao, PHD
Outcome results
None listed