Clinical trial NCT06598787: A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
Official title: A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Recurrent Glioblastoma
Lead sponsor: Sichuan Baili Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
First posted: 2024-09-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: Up to approximately 24 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 24 months
measure: Disease control rate (DCR)
timeFrame: Up to approximately 24 months
measure: Duration of response (DOR)
timeFrame: Up to approximately 24 months
measure: Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 24 months
measure: Cmax
timeFrame: Up to approximately 24 months
measure: Tmax
timeFrame: Up to approximately 24 months
measure: Ctrough
timeFrame: Up to approximately 24 months
measure: ADA (anti-drug antibody)
timeFrame: Up to approximately 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Wenbin Li, PHD
role: PRINCIPAL_INVESTIGATOR
References: