To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
NCT ID:
NCT06598787
Condition:
Recurrent Glioblastoma
Conditions: Official terms:
Glioblastoma
Recurrence
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-B01D1 for Injection
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
BL-B01D1 for Injection
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.
Criteria for 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;
4. Recurrent glioblastoma confirmed by pathology after failure of standard treatment;
5. KPS≥60;
6. The expected survival time as judged by the investigator was ≥3 months;
7. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined
by NCI-CTCAE v5.0;
8. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
9. 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;
10. Coagulation function: international normalized ratio (INR) ≤1.5, and activated
partial thromboplastin time (APTT) ≤1.5ULN;
11. Urine protein ≤2+ or < 1000mg/24h;
12. A pregnancy test must be performed within 7 days before starting treatment for
premenopausal women who are likely to have children, 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. 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;
2. A history of central nervous system hemorrhage/infarction requiring treatment
unrelated to antineoplastic drugs within 6 months before enrollment;
3. History of severe heart disease and cerebrovascular disease;
4. Prolonged QT interval, complete left bundle branch block, III degree
atrioventricular block, severe arrhythmia;
5. Unstable thrombotic events requiring therapeutic intervention within 6 months before
screening; Infusion-related thrombosis was excluded;
6. Active autoimmune and inflammatory diseases;
7. Other malignant tumors that progressed or required treatment within 5 years before
the first dose;
8. Hypertension poorly controlled by two antihypertensive drugs (systolic blood
pressure > 150 mmHg or diastolic blood pressure > 100 mmHg);
9. Patients with poor glycemic control or with diabetic gangrene;
10. Patients with a previous history of ILD, or current ILD or ≥G2 radiation
pneumonitis, or suspected to have such disease by imaging during screening;
11. Complicated with pulmonary diseases leading to clinically severe respiratory
function impairment;
12. Patients with a history of allergy to recombinant humanized or human-mouse chimeric
antibodies or to any of the excipients of BL-B01D1;
13. Received previous organ transplantation or allogeneic hematopoietic stem cell
transplantation (Allo-HSCT);
14. Human immunodeficiency virus antibody positive, active tuberculosis, active
hepatitis B virus infection or active hepatitis C virus infection;
15. Had a serious infection within 4 weeks before the first dose of study drug;
Indications of active pulmonary infection within 2 weeks before the first dose of
study drug;
16. Imaging examination indicated that the tumor had invaded or enveloped the large
vessels of the chest, neck, and pharynx, except for those that the investigator
thought would not affect the patient's enrollment in the drug;
17. Other circumstances that the investigator deemed inappropriate for participation in
the trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tiantan Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenbin Li
Start date:
October 17, 2024
Completion date:
October 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06598787
