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Trial Title:
A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors
NCT ID:
NCT05779163
Condition:
Advanced Malignant Tumors
Conditions: Official terms:
Neoplasms
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-033 for Injection
Description:
Initial dose - MTD; Q2W; intravenous infusion
Arm group label:
LBL-033
Other name:
LBL-033
Summary:
This trial is an open and multicenter phase I/II clinical study, which aims to evaluate
the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
Detailed description:
This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of
patients with advanced malignant tumors，which aims to evaluate the safety, tolerability,
PK characteristics, immunogenicity, and effectiveness.
The trial is divided into 2 parts: Phase 1 and Phase 2
Phase I study:
Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of
dose escalation data.
Phase II study:
Dose expansion included 4 cohorts that required patients with MUC16-positive
malignancies.Blood samples will be collected from all subjects in this trial.
Phase I and Phase II studies are expected to recruit 113-468 patients
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 years old when signing the informed consent form;
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is
0~1;
4. The expected survival time is at least 12 weeks;
5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at
least one measurable Target lesion;
6. Subject has adequate organ and bone marrow function，Conforming to laboratory test
results:
7. Males with fertility and females of childbearing age are willing to take effective
contraceptive measures From the signing of the informed consent form to within 6
months after the last administration of the trial drug (including abstinence,
intrauterine device, various hormonal contraception, correct use of contraception
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. Patients with active infection and currently requiring intravenous anti-infective
treatment；
3. Those who have clinically uncontrollable pleural effusion, pericardial effusion ,
requiring repeated drainage or medical intervention;
4. The patient has a Medical history of immunodeficiency, including HIV antibody
positive；
5. Women during pregnancy or lactation;
6. The investigator believes that the subject has other conditions that may affect
compliance or are not suitable for participating in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Recruiting
Contact:
Last name:
xue kong
Phone:
025-83378099-842
Email:
kongxue@leadsbiolabs.com
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510062
Country:
China
Status:
Recruiting
Contact:
Last name:
xue kong
Phone:
025-83378099-842
Email:
kongxue@leadsbiolabs.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
xue kong
Phone:
025-83378099-842
Email:
kongxue@leadsbiolabs.com
Facility:
Name:
Liaoning Cancer Hospital & Institute
Address:
City:
Shenyang
Zip:
110801
Country:
China
Status:
Recruiting
Contact:
Last name:
xue kong
Phone:
025-83378099-842
Email:
kongxue@leadsbiolabs.com
Facility:
Name:
Obstetrics & Gynecology Hospital of Fudan University
Address:
City:
Shanghai
Zip:
200011
Country:
China
Status:
Recruiting
Contact:
Last name:
xue kong
Phone:
025-83378099-842
Email:
kongxue@leadsbiolabs.com
Facility:
Name:
West China Second University Hospital,Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
xue kong
Phone:
025-83378099-842
Email:
kongxue@leadsbiolabs.com
Start date:
April 14, 2023
Completion date:
March 31, 2026
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/NCT05779163
