Combining BL-B01D1 and PD-1 Antibody for Advanced Triple-negative Breast Cancer

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of BL-B01D1+PD-1 Monoclonal Antibody Combination Therapy in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer

This study is testing a new combination treatment for people with advanced triple-negative breast cancer to see if it can help shrink their tumors.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06471205 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the safety and efficacy of a combination treatment using BL-B01D1 and a PD-1 monoclonal antibody in patients suffering from unresectable locally advanced or recurrent metastatic triple-negative breast cancer. The study aims to enroll participants who have not previously received systemic therapy for their condition and will assess the treatment's impact on tumor response. Eligible patients must provide tumor tissue samples and have measurable lesions as defined by RECIST criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with confirmed unresectable locally advanced or recurrent metastatic triple-negative breast cancer who have not received prior systemic therapy.

Not a fit: Patients with operable triple-negative breast cancer or those who have previously undergone systemic therapy for their condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat triple-negative breast cancer.

How similar studies have performed: Other studies exploring similar combinations of immunotherapy and targeted treatments have shown promising results, indicating potential for success in this approach.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Jiong Wu — Fudan University
• Study coordinator: Sa Xiao, PHD

Conditions Triple-negative Breast Cancer