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

HER2-positive Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06445400
• Other study ID #: BL-M07D1-205
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Sichuan Baili Pharmaceutical Co., Ltd.
• Contact: Sa Xiao, PHD
• Phone: 15013238943
• Email: xiaosa[@]baili-pharm.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer

Intervention

Drug:
• BL-M07D1
Administration by intravenous infusion for a cycle of 3 weeks.
• Pertuzumab
Administration by intravenous infusion for a cycle of 3 weeks.
• Docetaxel
Administration by intravenous infusion for a cycle of 3 weeks.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Baili Pharmaceutical Co., Ltd.	Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR)	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.	Up to approximately 24 months
Primary	Recommended Phase II Dose (RP2D)	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.	Up to approximately 24 months
Secondary	Progression-free Survival (PFS)	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.	Up to approximately 24 months
Secondary	Disease Control Rate (DCR)	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]).	Up to approximately 24 months
Secondary	Duration of Response (DOR)	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.	Up to approximately 24 months
Secondary	Treatment-Emergent Adverse Event (TEAE)	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.	Up to approximately 24 months