This is a Phase Ib clinical study to evaluate the efficacy and safety of TQB2618 injection as monotherapy and a combination regimen (with Penpulimab injection ± Anlotinib hydrochloride capsules) in the treatment of advanced colorectal cancer. 75 participants will be enrolled in the study. Objective response rate (ORR) as assessed by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 is the primary endpoint.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
TQB2618 is a monoclonal antibody targeting T cell immunoglobulin and mucin domain-3 (TIM-3) receptor.
Penpulimab is a humanized Immunoglobulin G-1 (IgG1) monoclonal antibody that binds to human programmed cell death 1 (PD-1), a cell membrane protein that is primarily expressed on activated T cells and inhibits T cell activation.
Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
Fuyang Cancer Hospital
Fuyang, Anhui, China
RECRUITINGHuai Nan First People's Hospital
Huainan, Anhui, China
NOT_YET_RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGMeizhou People's Hospital (Huangtang Hospital)
Meizhou, Guangdong, China
NOT_YET_RECRUITINGGuangxi Medical University Cancer Hospital
Nanning, Guangxi, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
NOT_YET_RECRUITINGJilin Cancer Hospital
Changchun, Jilin, China
RECRUITINGThe First Hospital of China Medical University
Shenyang, Liaoning, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, China
NOT_YET_RECRUITING...and 5 more locations
Objective response rate (ORR)
According to RECIST 1.1 or Modified RECIST 1.1 for immune based therapeutics, (iRECIST) criteria, the proportion of subjects whose confirmed tumor volume reduction reached the pre-specified value and maintained the minimum time-frame requirements, i.e., the proportion of subjects with complete response (CR) and partial response (PR).
Time frame: From first administration until disease progression or withdrawal due to other reasons, estimated to not exceed 8 months.
Overall survival (OS)
The time from randomization to death from any cause.
Time frame: Baseline up to death, estimated to not exceed 12 months
Progress free survival (PFS)
The time from randomization to the first disease progression or death from any cause, whichever occurs first.
Time frame: From randomization to the time of disease progression or death from any cause, estimated to not exceed 12 months.
Disease control rate (DCR)
Percentage of subjects with complete response, partial response, or stable disease as determined by RECIST 1.1 or iRECIST.
Time frame: From first administration to the time of disease progression or withdrawal from any cause, estimated to not exceed 12 months.
Duration of response (DOR)
From the time the tumor first assessed as complete or partial response to the time of first disease progression or death from any causes.
Time frame: From first administration to the time of disease progression or death from any cause, estimated to not exceed 12 months.
The incidence of adverse event (AE)
The incidence and severity of adverse events as determined by the Common Terminology Criteria for Adverse Events (CTC AE).
Time frame: From first administration to 28 days after withdrawal or the start time of the new anti-tumor treatment, whichever comes first.
Anti-drug antibodies (ADA)
The occurrence of ADA
Time frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, 30 days and 90 days after the last dose. Each cycle is 21 days.
Neutralizing antibodies (NaB)
The occurrence of neutralizing antibodies
Time frame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 8 Day 1, 30 days and 90 days after the last dose. Each cycle is 21 days.
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