A Phase I Clinical Study to Evaluate the Safety and Preliminary Efficacy of BC008-1A Injection in Subjects With Recurrent CNS WHO Grade 4 Glioma.

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.1 site in 1 country40 target enrollmentApril 7, 2025

ConditionsGlioma Glioma Tumor Recurrence Glioma, Recurrent High Grade Glioblastomas (GBM)Glioblastoma WHO Grade IV

InterventionsBC008-1A

DrugsBC008-1A

Overview

Phase: Phase 1
Intervention: BC008-1A
Conditions: Glioma
Sponsor: Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Enrollment: 40
Locations: 1
Primary Endpoint: Safety
Status: Recruiting
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.

Detailed Description

BC008-1A is an innovative bispecific antibody targeting TIGIT and PD-1, which is developed by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. . BC008-1A targets PD-1 and TIGIT to block the relevant signaling pathways, relieve the inhibition on T lymphocytes, thereby facilitating the activation of T cells and achieving the functions of immune surveillance, recognition and killing of tumor cells. Subjects with recurrent CNS WHO grade 4 glioma will be randomly assigned to dose group A (900 mg) or B (1200 mg) at a ratio of 1:1. BC008-1A will be administered once every 3 weeks until disease progression, intolerable toxicity, withdrawal of informed consent, loss to follow-up, initiation of new anti-tumor treatment, the decision of the investigator for the subject to withdraw based on the subject's benefit situation, death or other circumstances, whichever occurs first.

Registry

clinicaltrials.gov

Start Date

April 7, 2025

End Date

December 1, 2026

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the informed consent form;
•Recurrent CNS WHO grade 4 glioma: Subjects with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment and have no surgical plan;
•Male or female aged ≥ 18 years old;
•Expected survival time ≥ 12 weeks;
•According to the RANO criteria, there is at least one measurable intracranial tumor lesion;
•Have sufficient hematological function, liver function and renal function, and meet the following laboratory test results before enrollment (withoutusing any cell growth factors, platelet and red blood cell transfusion or other blood transfusion treatments within 1 week before the first dose of study treatment):
•Basically normal liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN (patients with known Gilbert disease with serum bilirubin level ≤3 × ULN can be included), alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate aminotransferase (AST) ≤ 2.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN;
•Basically normal renal function: Creatinine (Cr) ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min;
•Basically normal coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for subjects receiving anticoagulant treatment, the investigator judges that INR, PT and APTT are within the safe and effective treatment range and there is no clinical condition of active bleeding or increased bleeding risk);
•Basically normal hematological system: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (without granulocyte colony-stimulating factor treatment), platelet (PLT) ≥ 100 × 10\^9/L, hemoglobin (Hb) ≥ 90 g/L, white blood cell count ≥ 2.0 × 10\^9/L, lymphocyte count ≥ 0.5 ×10\^9/L.

Exclusion Criteria

•Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs;
•Having suffered from other malignant tumors and currently requiring treatment (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin that have been adequately treated);
•Having an autoimmune disease or a history of autoimmune diseases or related symptoms;
•Subjects who cannot undergo MRI (such as those with a pacemaker implanted, non-removable metal dentures, claustrophobia, etc.);
•Subjects who have received chemotherapy (those who have used nitrosourea drugs within 42 days before the first receipt of the experimental drug cannot be enrolled), radiotherapy, biotherapy, endocrine therapy, targeted therapy, tumor-treating fields therapy, immunotherapy or other anti-tumor treatments such as anti-tumor Chinese patent medicines within 28 days before the first use of the study drug or within 5 half-lives of the drug (whichever is shorter), or subjects who have received any clinical study treatment and the interval from the first use of the study drug is ≤ 28 days;
•Subjects with tumor lesions involving the brainstem, spinal cord or leptomeningeal dissemination and metastasis;
•Those who have used corticosteroids within 1 month before participating in the trial and have received systemic treatment with a daily dose higher than 3 mg of dexamethasone or an equivalent dose of other hormones;
•The toxicity caused by previous anti-tumor treatments has not decreased to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities judged by the investigator to have no safety risks, such as alopecia, grade 2 peripheral neurotoxicity, hypothyroidism stabilized by hormone replacement therapy, etc.);
•Those who have received live attenuated vaccines within 4 weeks before the first administration of the study drug or plan to receive them during the study period;
•Subjects with active infections at present (such as acute bacterial infections, tuberculosis, pulmonary infections, etc.);