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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
RECRUITINGSafety
Assesing the type, frequency, severity, and duration of adverse events.
Time frame: Up to 2 years
objective response rate (ORR)
Defined as the proportion of patients who have a complete response (CR) or a partial response (PR) per RANO.
Time frame: Up to 2 years
Maximum Plasma Concentration (Cmax)
Time frame: 3 months
Immunogenicity
The number and incidence of subjects with anti-drug antibodies (ADA).
Time frame: Up to 2 years
Karnofsky performance score(KPS)
To evaluate the change of KPS from baseline.
Time frame: Up to 2 years
Recommended phase II dose
To determine the recommended dose for the Phase II clinical study based on the results of safety, preliminary efficacy and pharmacokinetics
Time frame: Up to 2 years
Progression-free survival(PFS)
The time interval from the first drug administration to progression per RANO or death from any cause
Time frame: Up to 2 years
Overall survival (OS)
The time interval from the first drug administration to death due to any cause.
Time frame: Up to 2 years
Duration of overall response (DoR)
the time interval from the first discovery of response (CR or PR) to progression per RANO or death from any cause
Time frame: Up to 2 years
Disease control rate (DCR)
Defined as the proportion of subjects who achieved a best response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) per RANO.
Time frame: Up to 2 years
Time to response (TTR)
The time from the first drug administration to the first confirmation of Complete Response (CR) or Partial Response (PR) per RANO.
Time frame: Up to 2 years
Area under the curve (AUC)
Time frame: 3 months
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