A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma

Sichuan Baili Pharmaceutical Co., Ltd.1 site in 1 country20 target enrollmentOctober 17, 2024

ConditionsRecurrent Glioblastoma

InterventionsBL-B01D1 for Injection

DrugsBL-B01D1 for Injection

Overview

Phase: Phase 2
Intervention: BL-B01D1 for Injection
Conditions: Recurrent Glioblastoma
Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: 12 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, multicenter, phase II study to evaluate the safety, efficacy, and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with recurrent glioblastoma.

Registry

clinicaltrials.gov

Start Date

October 17, 2024

End Date

October 2026

Last Updated

12 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent form voluntarily and follow the protocol requirements;
•Gender is not limited;
•Age: ≥18 years old;
•Recurrent glioblastoma confirmed by pathology after failure of standard treatment;
•The expected survival time as judged by the investigator was ≥3 months;
•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%;
•No blood transfusion, albumin, colony-stimulating factor, any cell growth factor and/or platelet-raising drugs are allowed within 14 days before the first dose of study drug, and the organ function level must meet the requirements;
•Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
•Urine protein ≤2+ or \< 1000mg/24h;

Exclusion Criteria

•Chemotherapy, biological therapy, immunotherapy, etc., had been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy had been used within 5 days, palliative radiotherapy, modern Chinese medicine preparations approved by NMPA for anti-tumor treatment had been used within 2 weeks;
•A history of central nervous system hemorrhage/infarction requiring treatment unrelated to antineoplastic drugs within 6 months before enrollment;
•History of severe heart disease and cerebrovascular disease;
•Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia;
•Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
•Active autoimmune and inflammatory diseases;
•Other malignant tumors that progressed or required treatment within 5 years before the first dose;
•Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
•Patients with poor glycemic control or with diabetic gangrene;
•Patients with a previous history of ILD, or current ILD or ≥G2 radiation pneumonitis, or suspected to have such disease by imaging during screening;

Arms & Interventions

BL-B01D1 for Injection

Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Intervention: BL-B01D1 for Injection

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: 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.