Trial Title:
TQB2223 Injection in Combination With Penpulimab in Patients With Advanced Cancers
NCT ID:
NCT05894421
Condition:
Advanced Cancer
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB2223 injection+ Penpulimab Injection
Description:
TQB2223 is an anti lymphocyte activation gene-3 (LAG-3) antibody. Penpulimab Injection is
an anti-PD-1 antibody.
Arm group label:
TQB2223 injection+ Penpulimab Injection
Summary:
TQB2223 is a recombinant, fully humanized antibody that binds lymphocyte activation
gene-3 (LAG-3) and blocks the LAG-3/ major histocompatibility complex class II (MHC-II)
interaction, thus allowing for increased T-cell proliferation and cytokine production.
This is a phase I study to evaluate the safety, tolerability, pharmacokinetics (PK) and
effectiveness of TQB2223 injection in combination with Penpulimab in subjects with
advanced cancers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Evidence of a personally signed and dated informed consent document indicating that
the patient has been informed of all pertinent aspects of the study;
- Male or female patient 18 to 75 years of age, an Eastern Cooperative Oncology Group
(ECOG) performance status of 0 to 1, and life expectancy ≥3 months;
- Histologically or cytologically confirmed malignancies;
- Subjects with advanced malignant tumors who failed standard treatment or lacked
effective treatment;
- Patient has at least one evaluable lesion assessed by RECIST 1.1;
- The main organs function is well;
- Male or female patient had no plans to become pregnant and voluntarily take
effective contraceptive measures during study period until at least 6 months after
the last dose of study drug.
Exclusion Criteria:
- Concurrent secondary malignancy. or other malignancy with no evidence of disease for
more than 5 years;
- History of uncontrolled intercurrent illness;
- Major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 4
weeks prior to first dose;
- Prior treatment targeting LAG-3;
- Unstable or serious concurrent medical conditions, as assessed by the Investigators,
that would substantially increase the risk-benefit ratio of participating in the
study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hui Wu, Bachelor
Phone:
13509320201
Email:
kkw123@163.com
Facility:
Name:
Cancer Hospital of Guizhou Medical University
Address:
City:
Guiyang
Zip:
550001
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Wu, Doctor
Phone:
15885541781
Email:
wutao03417@sina.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Yanqiu Zhao, Doctor
Phone:
13938252350
Email:
13938252350@163.com
Facility:
Name:
The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Address:
City:
Changsha
Zip:
410006
Country:
China
Status:
Recruiting
Contact:
Last name:
Yajun Li, Doctor
Phone:
18273175031
Email:
liyajun@hnca.org.cn
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wuping Li, Doctor
Phone:
13870659916
Email:
18907001021@163.com
Facility:
Name:
The second hospital of Dalian medical university
Address:
City:
Dalian
Zip:
116027
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xiuhua Sun, Master
Phone:
17709873631
Email:
3038668@vip.sina.com
Facility:
Name:
Tongji Hospital of Tongji University
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Recruiting
Contact:
Last name:
Ping Li, Doctor
Phone:
13564181131
Email:
Lilyforever76@126.com
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
Lei Liu, Doctor
Phone:
+86 18980606231
Email:
Clinical_Liu66@163.com
Contact backup:
Last name:
Li Zheng, Doctor
Phone:
+86 18980601950
Email:
18980601950@163.com
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Contact:
Last name:
Runxiang Yang, Master
Phone:
13888876721
Email:
13888876721@163.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310022
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongling Ji, Doctor
Phone:
+86 13958085251
Email:
jiyl@zjcc.org.cn
Facility:
Name:
The First Affiliated Hospital of Ningbo University
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Recruiting
Contact:
Last name:
Lixia Sheng, Doctor
Phone:
15968985233
Email:
Slx800408@163.com
Start date:
June 6, 2023
Completion date:
January 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05894421
