A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

Last updated: May 6, 2025
Sponsor: Nanjing Leads Biolabs Co.,Ltd
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neoplasms

Treatment

LBL-033 for Injection

Clinical Study ID

NCT05779163
LBL-033-CN001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Agree to follow the experimental treatment plan and visit plan, join the groupvoluntarily, 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 atleast one measurable Target lesion;

  6. Subject has adequate organ and bone marrow function,Conforming to laboratory testresults:

  7. Males with fertility and females of childbearing age are willing to take effectivecontraceptive measures From the signing of the informed consent form to within 6months after the last administration of the trial drug (including abstinence,intrauterine device, various hormonal contraception, correct use of contraceptionSets,etc); Women of childbearing age include pre-menopausal women and women within 2years after menopause. Women of childbearing age must have a negative pregnancy testwithin 7 days before the first trial drug is administered.

Exclusion

Exclusion Criteria:

  1. Have received other unmarketed clinical research drugs or treatments within 4 weeksbefore using the research drug for the first time;

  2. Patients with active infection and currently requiring intravenous anti-infectivetreatment;

  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 antibodypositive;

  5. Women during pregnancy or lactation;

  6. The investigator believes that the subject has other conditions that may affectcompliance or are not suitable for participating in this study.

Study Design

Total Participants: 468
Treatment Group(s): 1
Primary Treatment: LBL-033 for Injection
Phase: 1/2
Study Start date:
April 14, 2023
Estimated Completion Date:
March 31, 2026

Study 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

Connect with a study center

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510062
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning 110801
    China

    Active - Recruiting

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai 200011
    China

    Active - Recruiting

  • West China Second University Hospital,Sichuan University

    Chengdu, Sichuan 610044
    China

    Active - Recruiting

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