An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.
This trial is an open-label, multicenter, phase II clinical study of LBL-024 in combination with other drugs for the treatment of patients with Advanced biliary tract cancer (BTC) and hepatocellular carcinoma (HCC), to evaluate the efficacy and safety of LBL-024 combination therapy.The trial included two cohorts. Cohort 1: This cohort will have a safety run-in period,a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After the subjects completed the 21-day safety observation, the sponsor and investigator jointly assessed the safety and tolerability of the combination drugs. If the safety and tolerability are good, the extension study of combination administration will be continued, the subjects will be continued to be enrolled. Cohort 2: This cohort will have a safety run-in period, a small number of subjects will be enrolled to receive LBL-024 Combination Administration. After completing the 21-day safety observation, the safety and tolerability of the combination drugs will be assessed. The sponsor and investigator assessed the safety and tolerability of the combination drugs as good,and then the cohort will continue to enroll subjects,the extension study of combination administration will be continued. The trial will enroll up to 140 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Intravenous infusion.
Intravenous infusion.
Intravenous infusion.
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGHenan Cancer Hospital
Zhengzhou, Henan, China
RECRUITINGXiangyang Central Hospital
Xiangyang, Hubei, China
Objective Response Rate (ORR)
Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Disease Control Rate(DCR)
Percentage of participants achieving CR and PR and stable disease (SD).
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Duration of Response(DOR)
The period from the participants first achieving CR or PR to disease progression.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Cmax
Maximum drug concentration in plasma after administration.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
Tmax
After administration,Time to reach maximum drug concentration in plasma.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)
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Intravenous infusion.
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
RECRUITINGShandong Cancer Hospital
Jinan, Shandong, China
NOT_YET_RECRUITINGZhongshan Hospital of Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGSir Run Run Shaw Hospital (SRRSH) Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGZhejiang Cancer Hospital
Hangzhou, Zhejiang, China
RECRUITINGimmunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects.
Time frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy)