Trial Title:
A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors
NCT ID:
NCT05516914
Condition:
Malignant Tumors
Conditions: Official terms:
Neoplasms
Cisplatin
Gemcitabine
Docetaxel
Tislelizumab
Study type:
Interventional
Study phase:
Phase 1/Phase 2
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:
LBL-007 Injection
Description:
Initial dose - MTD; Q3W; intravenous infusion
Arm group label:
LBL-007 & Tislelizumab
Other name:
LBL-007
Intervention type:
Drug
Intervention name:
Tislelizumab Injection
Description:
Initial dose; Q3W; intravenous infusion
Arm group label:
LBL-007 & Tislelizumab
Other name:
Tislelizumab
Intervention type:
Drug
Intervention name:
Cisplatin Injection
Description:
Initial dose；Q3W; intravenous infusion
Arm group label:
LBL-007 & Tislelizumab
Other name:
Cisplatin
Intervention type:
Drug
Intervention name:
Gemcitabine Hydrochloride for Injection
Description:
Initial dose；Q3W; intravenous infusion
Arm group label:
LBL-007 & Tislelizumab
Other name:
Gemcitabine Hydrochloride
Intervention type:
Drug
Intervention name:
Docetaxel injection
Description:
Initial dose；Q3W; intravenous infusion
Arm group label:
LBL-007 & Tislelizumab
Other name:
Docetaxel
Summary:
This trial is an open and multicenter phase Ib/II clinical study, which aims to evaluate
the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
Detailed description:
This is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with
Tislelizumab in the treatment of malignant tumors，which aims to evaluate the safety,
tolerability, PK characteristics, immunogenicity, and effectiveness.
The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK
expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H.
Part B ~ Part H will be designed and conducted based on the safety , tolerability and PK
analysis of the Part A Study Part, after RP2D is determined, will be used for Part B ~
Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size
shall be subject to actual occurrence)
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Agree to follow the experimental treatment plan and visit plan, join the group
voluntarily, and sign a written informed consent form;
2. Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of
gender;
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS
is 0~1;
4. The expected survival time is at least 12 weeks;
5. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1),
the subjects enrolled have at least one measurable tumor lesion;
6. Subject has adequate organ and bone marrow function
7. Males with fertility and females of childbearing age are willing to take effective
contraceptive measures (including abstinence, intrauterine device, various hormonal
contraception, correct use of contraception from the signing of the informed consent
form to 6 months after the last administration of the trial drug Sets, etc.); women
of childbearing age include pre-menopausal women and women within 2 years after
menopause. Women of childbearing age must have a negative pregnancy test within 7
days before the first trial drug is administered.
Exclusion Criteria:
1. Have received other unmarketed clinical research drugs or treatments within 4 weeks
before using the research drug for the first time;
2. Those who have clinically uncontrollable pleural effusion, pericardial effusion or
ascites, requiring repeated drainage or medical intervention;
3. Women during pregnancy or lactation;
4. The investigator believes that the subject has other conditions that may affect
compliance or are not suitable for participating in this study.
5. Patients with history of severe cardiovascular and cerebrovascular diseases.
6. Patients with active infection and currently requiring intravenous anti-infective
treatment
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anhui Cancer Hospital
Address:
City:
Hefei
Zip:
230031
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Sun Yat-Sen Memorial Hospital，Sun Yat-Sen University
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Huizhou Municipal Central Hospital
Address:
City:
Huizhou
Zip:
516000
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
The Jiangmen Central Hospital
Address:
City:
Jiangmen
Zip:
440700
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Maoming People's Hospital
Address:
City:
Maoming
Zip:
525000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
DongTao Meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Central People's Hospital of Zhanjinag
Address:
City:
Zhanjiang
Zip:
524000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
DongTao Meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Guangxi Tumour Hospital
Address:
City:
Nanning
Zip:
530000
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
The First Affiliated Hospital of Guangxi Medical University
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
The First People's Hospital of Yu Lin
Address:
City:
Yulin
Zip:
537000
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
The Second Affiliated Hospital of Hainan Medical University
Address:
City:
Haikou
Zip:
570000
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Zip:
430000
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Union Hospital Tongji Medical College Huazhong University of Science And Technology
Address:
City:
Wuhan
Zip:
430022
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410000
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
201100
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
dongtao meng
Phone:
02583378099
Email:
mengdongtao@leadsbiolabs.com
Start date:
September 1, 2022
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Nanjing Leads Biolabs Co.,Ltd
Agency class:
Industry
Source:
Nanjing Leads Biolabs Co.,Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05516914
