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TQB2618 administered intravenously (IV) on Day 1 of each 21-day.

TQB2618 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2618 is diluted to 100 m with normal saline \[0.9% (w/v) sodium chloride solution\], and the infusion time is 60 ± 10 min.

TQB2618 injection

Yun Fan, Doctor

TQB2618 is a TIM-3 receptor monoclonal antibody that binds to the extracellular domain of TIM-3 outside the cell to block the binding of TIM-3 to its ligand, thereby inhibiting the downstream signal transduction of TIM-3 and deactivating TIM-3 Inhibition of immune cells. The purpose of this study was to evaluate the safety, tolerability, pharmacokinetic parameters and antitumor effects of TQB2618 injection in subjects with advanced solid tumors.

A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors

A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors

MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.

To characterize the pharmacokinetics of TQB2618 by assessment of time to reach maximum plasma concentration.

Cmax is the maximum plasma concentration of TQB2618 or metabolite(s).

t1/2 is time it takes for the blood concentration of TQB2618 injection or metabolite(s) to drop by half.

To characterize the pharmacokinetics of TQB2618 by assessment of area under the plasma concentration time curve from zero to infinity.

Receptor occupation of TIM-3 after single and multiple doses

Percentage of participants achieving complete response (CR) and partial response (PR).

PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.

Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Amino Acids

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunoglobulin G

Tyrosine Kinase Inhibitors

Immunoglobulins, Intravenous

Tyrosine

TQB2618 injection combined with Penpulimab injection and Anlotinib hydrochloride capsules, 3 weeks as a treatment cycle.

TQB2618 injection combined with Penpulimab injection, 3 weeks as a treatment cycle.

TQB2618 injection, 3 weeks as a treatment cycle.

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.

Penpulimab injection

Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.

Anlotinib hydrochloride capsules

Ruihua Xu, Doctor

Hesheng Qian, Bachelor

Yanshun Zhang, Bachelor

Rongbo Lin, Bachelor

Jiayi Li, Master

Xiwen Huang, Bachelor

Yongqiang Li, Master

Zhenyang Liu, Doctor

Ying Cheng, Doctor

Xiujuan Qu, Doctor

Hai chuan Su, Doctor

Aili Suo, Doctor

Junye Wang, Bachelor

Wenhui Yang, Doctor

Jing Tian, Master

Xiaobo Du, Doctor

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.

A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer.

A Phase Ib Clinical Study to Evaluate the Efficacy and Safety of of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer.

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).

The time from randomization to death from any cause.

The time from randomization to the first disease progression or death from any cause, whichever occurs first.

Percentage of subjects with complete response, partial response, or stable disease as determined by RECIST 1.1 or iRECIST.

From the time the tumor first assessed as complete or partial response to the time of first disease progression or death from any causes.

The incidence and severity of adverse events as determined by the Common Terminology Criteria for Adverse Events (CTC AE).

The occurrence of neutralizing antibodies

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Intravenous infusion of TQB2618 Injection 1200mg and Penpulimab Injection 200mg on 1st day, combining with Anlotinib capsules 10mg given orally in fasting conditions once daily in each 21-day cycle. (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)

Penpulimab is an inhibitor of programmed cell death 1 (PD-1).

TQB2618 injection is an inhibitor of T cell immunoglobulin and mucin domain-containing protein 3 (TIM-3).

Anlotinib Hydrochloride Capsules

Qiang Xia, Doctor

Hao Feng, Doctor

Wenhua Zhang, Bachelor

Hua Li, Doctor

Rongshu Shi, Doctor

Tongsen Zheng, Doctor

Gongbin Chen, Bachelor

Jia Luo, Doctor

Wei Wu, Master

Kui Wang, Doctor

This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQB2618 injection combined with penpulimab injection and Anlotinib Hydrochloride Capsules in patients with advanced HCC.

A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).

A Phase Ib Clinical Study to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules as First-line Treatment for Advanced Hepatocellular Carcinoma.

Percentage of subjects achieving complete response (CR) and partial response (PR).

OS is defined as the time from the first time the subject received treatment to death due to any cause.

The time from the first administration of the drug to disease progression or death (whichever occurs first).

Percentage of subjects achieving CR and PR and stable disease (SD) is greater than or equal to 4-6 weeks.

The time from the first assessment of the tumor's CR or PR to the disease's first progression or death from various causes.

The incidence of ADA after the administration of TQB2618.

The incidence of Nab after the administration of TQB2618.

All adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0).

It refers to adverse medical events such as death, life-threatening, permanent, or serious disability or loss of function, hospitalization or prolonged hospitalization, and congenital abnormalities or birth defects after the subject receives the experimental drug.

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

TQB2618 injection combined with Toripalimab injection，21 days as a treatment cycle.

Monoclonal antibody against Programmed death factor receptor 1

Toripalimab injection

Jun Guo, Doctor

SiMing Li, Doctor

Jun Guo

This study is an open, single-center, multi-cohort phase Ib exploratory study, and 50 subjects are planned to be enrolled to observe the objective response rate of each subject. The safety evaluation of this study adopts common terminology criteria for adverse events version (CTCAE) 5.0 to evaluate the adverse events of drugs. Efficacy was evaluated using response evaluation criteria in solid tumors version (RECIST) 1.1 for immune-based therapeutics criteria.

Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma

Phase Ib Clinical Trial to Evaluate the Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma

Certain adverse events related to the test drug occurred within 1 treatment cycle (21 days) of the subjects' first dose

Optimal tolerated dose determined after the end of phase 1

The proportion of subjects with complete response (CR) and partial response (PR) whose tumor volume reduced to a predetermined value and maintained the minimum time limit (at the time of the next imaging evaluation)

The time between the onset of first medication and disease progression (PD) or death before PD

The ratio of disease control cases (Partial Remission+Complete Response+Partial Remission ) to total cases was calculated

From the time of the patient's first treatment to the time of death from any cause

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors	NCT04623892	Advanced Solid ...	TQB2618 injecti...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB2618 Injection in Subjects With Advanced Solid Tumors	NCT04623892	Advanced Solid ...	TQB2618 injecti...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer.	NCT06010901	Colorectal Canc...	TQB2618 injecti... Penpulimab inje... Anlotinib hydro...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of TQB2618 Injection Combined With Penpulimab Injection and Anlotinib Hydrochloride Capsules for First-line Treatment of Advanced Hepatocellular Carcinoma (HCC).	NCT05975645	Advanced Hepato...	Penpulimab inje... TQB2618 injecti... Anlotinib Hydro...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Clinical Study of TQB2618 Injection Monotherapy and Combination Regimen (With Penpulimab Injection ±Anlotinib Hydrochloride Capsules) in the Four or Later Lines of Treatment of Advanced Colorectal Cancer.	NCT06010901	Colorectal Canc...	TQB2618 injecti... Penpulimab inje... Anlotinib hydro...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Efficacy and Safety of TQB2618 Injection Combined With Toripalimab Injection in Patients With Advanced Melanoma	NCT05451407	Melanoma	TQB2618 injecti... Toripalimab inj...	18 Years - 75 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Spots Global Cancer Trial Database for tqb2618 injection