Status:
RECRUITING
A Study of BL-B16D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors
Lead Sponsor:
Sichuan Baili Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Conditions:
Breast Cancer
Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is an open, multicenter, increasing dose and dose extension nonrandomized phase I clinical study to evaluate the safety, tolerability, pharmacokinetics characteristics and preliminary effic...
Eligibility Criteria
Inclusion
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Gender is not limited;
- Age: ≥18 years old and ≤75 years old (stage Ia); ≥18 years old (stage Ib);
- Expected survival time ≥3 months;
- 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;
- Consent to provide archival tumor tissue samples or fresh tissue samples from primary or metastatic lesions within 3 years;
- Must have at least one extracranial measurable lesion that meets the RECIST v1.1 definition;
- 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%;
- 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;
- Coagulation function: international normalized ratio ≤1.5, and activated partial thromboplastin time ≤1.5ULN;
- Urinary protein ≤2+ or ≤1000mg/24h;
- 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
- 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;
- History of severe heart disease;
- Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block;
- Active autoimmune and inflammatory diseases;
- Patients with other malignant tumors or a history of other malignant tumors;
- Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
- Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- Patients with poor glycemic control;
- 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;
- Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
- Patients with primary central nervous system (CNS) tumors or CNS metastases that had failed local treatment;
- Patients with a history of allergy to recombinant humanized antibody or human-mouse chimeric antibody or to any of BL-B16D1's excipients;
- Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
- 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;
- Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
- 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;
- Patients with massive or symptomatic effusions, or poorly controlled effusions;
- Had participated in another clinical trial within 4 weeks before the first dose (calculated from the time of the last dose);
- 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.;
- Other circumstances that the investigator deemed inappropriate for participation in the trial.
Key Trial Info
Start Date :
August 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06493864
Start Date
August 26 2024
End Date
July 1 2026
Last Update
September 18 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China