A Phase I/II Clinical Study of LBL-024 in Patients With Advanced Malignant Tumors
- Registration Number
- NCT05170958
- Lead Sponsor
- Nanjing Leads Biolabs Co.,Ltd
- Brief Summary
To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors
- Detailed Description
This trial is a single-arm, open-label, phase I/II clinical study of LBL-024 in patients with advanced malignant tumors. The phase I dose escalation and PK expansion phase plans to include patients with advanced malignant tumors who have failed previous standard treatment or do not have standard treatment or are not applicable to standard treatment at this stage. The phase IIa indication expansion phase plans to include patients with advanced malignant tumors , and evaluate the safety, tolerability, pharmacokinetic (PK) characteristics, immunogenicity and preliminary efficacy. Single-arm registry clinical study to be conducted in Phase IIb.
This trial includes two parts:
Part I: A Phase I/IIa clinical study on the safety, tolerability, PK and efficacy of LBL-024 in patients with advanced malignant tumor.
Part II:Phase IIb is a pivotal single-arm clinical study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 396
- Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;
- 18-75 years old (including boundary value), no gender limit in the I/IIa trial phase；18-80 years old (including boundary value), no gender limit in the IIb trial phase；
- Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- The expected survival time is at least 12 weeks
- ECOG score is 0-1
- 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.
- Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment;
- medical history of immunodeficiency including positive HIV antibody test;
- Women who are pregnant or breastfeeding;
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LBL-024 LBL-024 for Injection LBL-024 injection; Initial dose - MTD; Q3W
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 3 weeks of starting treatment in Phase I study.
Objective Response Rate (ORR) All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST V1.1. It was used to evaluate the efficacy of LBL-024 in Phase II study.
Dose-limiting toxicities（DLT) Within 3 weeks after receiving the first dose of the test drug During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related) in Phase I study.
- Secondary Outcome Measures
Name Time Method Adverse events and serious adverse events All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） Laboratory examination, physical examination, vital signs and electrocardiogram, etc.
Disease Control Rate(DCR) Visit 30 days after discontinuation of treatment or withdraw from the visit Defined as percentage of participants having CR, PR, iCR，iPR or SD as best on-study response
Progression-free survival (PFS) All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal（Visit 30 days after discontinuation of treatment or withdraw from the visit） Defined as the time from random assignment in a clinical trial to disease progression or death from any cause, has recently become an endpoint of considerable interest in the study of new oncology drugs.
Immunogenicity All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） Incidence of subjects with anti-drug antibody (ADA) and neutralizing antibody (if applicable)
Maximum serum concentration (Cmax) All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit） To determine the PK profile of LBL-024
Trial Locations
- Locations (49)
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
Anyang Tumor Hospital
🇨🇳Anyang, Henan, China
Wuhan Union Hospital of China
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institute
🇨🇳Nanning, Guangxi, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Sir Run Run Shaw Hospital
🇨🇳Hangzhou, Hangzhou, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Chongqing Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China
The Second Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
🇨🇳Guanzhou, Guangdong, China
Jiangsu Cancer Hospital
🇨🇳Nanjing, Jiangsu, China
The Ferst Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Ch'ang-ch'un, Jilin, China
Liaoning Cancer Hospital & Institute
🇨🇳Shenyang, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
Shandong Cancer Hospital & Institute
🇨🇳Jinan, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Mianyang Central Hospital
🇨🇳Mianyang, Sichuan, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Cancer Hospital Chinese Academy of Medical Sciences
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital,Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
The First Affilated Hospital of Henan University of Science & Technology
🇨🇳Luoyang, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
The Second Affiliated Hospital Nanchang University
🇨🇳Nanchang, Jiangxi, China
Nanjing First Hospital
🇨🇳Nanjing, Jiangsu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, Jiangsu, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
The First Affiliated Hospital of Xi'An Jiaotong University
🇨🇳Xi'an, Shanxi, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
The First Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Fujian Cancer Hospital
🇨🇳Fuzhou, Fujian, China