Evaluating BL-B16D1 for advanced breast cancer and solid tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics Characteristics and Preliminary Efficacy of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumor

This study is testing a new treatment called BL-B16D1 to see if it is safe and effective for people with advanced breast cancer and other solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Chemotherapy, radiation, doxorubicin
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06493864 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter phase I clinical study aims to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of BL-B16D1 in patients with unresectable locally advanced or metastatic breast cancer and other solid tumors. The study involves increasing doses of the treatment to determine the optimal dosage and monitor patient responses. Participants will be closely monitored for any adverse effects and overall health outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with confirmed unresectable locally advanced or metastatic breast cancer or other solid tumors who have failed or are ineligible for standard therapies.

Not a fit: Patients with severe cardiac dysfunction or those who do not meet the eligibility criteria, such as having a life expectancy of less than three months, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced breast cancer and other solid tumors who have exhausted standard treatment options.

How similar studies have performed: While this approach is part of ongoing research in cancer treatment, the specific use of BL-B16D1 in this context is novel and has not been extensively tested in previous studies.

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 (stage Ia); ≥18 years old (stage Ib);
4. Expected survival time ≥3 months;
5. Patients with histologically and/or cytologically confirmed unresectable locally advanced or metastatic breast cancer and other solid tumors who failed or could not receive standard treatment;
6. Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;
7. Must have at least one extracranial measurable lesion that meets the RECIST v1.1 definition;
8. 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. The organ function level must meet the requirements if the patient has not received blood transfusion or hematopoietic stimulation factor therapy within 14 days before the first dose;
12. Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;
13. Urinary protein ≤2+ or ≤1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients (male or female) should use adequate contraception throughout the treatment cycle and for 6 months after completion of treatment.

Exclusion Criteria:

1. Chemotherapy, biological therapy and other anti-tumor therapies have been used within 4 weeks or 5 half-lives before the first dose; Mitomycin and nitrosoureas were administered within 6 weeks before the first dose; Oral drugs such as fluorouracil;
2. History of severe heart disease;
3. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block;
4. Active autoimmune and inflammatory diseases;
5. Patients with other malignant tumors or a history of other malignant tumors;
6. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
7. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
8. Patients with poor glycemic control;
9. Patients with grade ≥1 radiation pneumonitis according to the RTOG/EORTC definition; Previous history of ILD or current ILD, or suspicion of such disease during screening;
10. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
11. Patients with primary central nervous system (CNS) tumors or CNS metastases that had failed local treatment;
12. Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B16D1's excipients;
13. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
14. In previous (new) adjuvant anthracyclines, the cumulative dose of anthracyclines for doxorubicin \> 550 mg/m2, epirubicin \> 900 mg/m2 or the equivalent dose of other similar drugs;
15. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
16. Serious infection occurred within 4 weeks before the first dose; Signs of pulmonary infection or active pulmonary inflammation within 2 weeks before the first dose;
17. Patients with massive or symptomatic effusions, or poorly controlled effusions;
18. Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
19. Had the following eye diseases: a. active infection or corneal ulcer; b. monocular vision; c. a history of corneal transplantation; d. Contact lens dependence; e. Uncontrolled glaucoma; f. Uncontrolled or progressive retinopathy, wet macular degeneration, etc.;
20. Other circumstances that the investigator deemed 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 Breast Cancer; Solid Tumor