A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors
A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant Tumors.
1 other identifier
interventional
468
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2023
Typical duration for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 7, 2023
CompletedFirst Posted
Study publicly available on registry
March 22, 2023
CompletedStudy Start
First participant enrolled
April 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedMay 7, 2025
April 1, 2025
3 years
March 7, 2023
May 6, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Dose-limiting toxicities（DLT）
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
At the end of Cycle 1（28 days after the first prespecified dose）
Maximum tolerated dose (MTD)
MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first cycles
At the end of Cycle 1（28 days after the first prespecified dose）
Secondary Outcomes (6)
Cmax
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Tmax
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
immunogenicity
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Disease Control Rate(DCR）
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Duration of Response(DOR）
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
- +1 more secondary outcomes
Study Arms (1)
LBL-033
EXPERIMENTALLBL-033 for Injection; Initial dose - MTD; Q2W
Interventions
Eligibility Criteria
You may qualify if:
- Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
- Age ≥ 18 years old when signing the informed consent form;
- The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0\~1;
- The expected survival time is at least 12 weeks;
- According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion;
- Subject has adequate organ and bone marrow function，Conforming to laboratory test results:
- 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.
You may not qualify if:
- Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
- Patients with active infection and currently requiring intravenous anti-infective treatment；
- Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention;
- The patient has a Medical history of immunodeficiency, including HIV antibody positive；
- Women during pregnancy or lactation;
- The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510062, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110801, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200011, China
West China Second University Hospital,Sichuan University
Chengdu, Sichuan, 610044, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jihong liu
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 7, 2023
First Posted
March 22, 2023
Study Start
April 14, 2023
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
May 7, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share