A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors
NCT ID: NCT05779163
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
468 participants
INTERVENTIONAL
2023-04-14
2026-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LBL-033
LBL-033 for Injection; Initial dose - MTD; Q2W
LBL-033 for Injection
Initial dose - MTD; Q2W; intravenous infusion
Interventions
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LBL-033 for Injection
Initial dose - MTD; Q2W; intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Nanjing Leads Biolabs Co.,Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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jihong liu
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
West China Second University Hospital,Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LBL-033-CN001
Identifier Type: -
Identifier Source: org_study_id
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