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.

This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

Study Overview

• Status: Completed
• Conditions: Advanced Malignant Tumors
• Intervention / Treatment: Drug: LBL-033 for Injection

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350014
      • Fujian Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510062
      • Sun Yat-Sen University Cancer Center
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Cancer Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110801
      • Liaoning Cancer Hospital & Institute
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200011
      • Obstetrics & Gynecology Hospital of Fudan University
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • West China Second University Hospital,Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LBL-033; LBL-033 for Injection; Initial dose - MTD; Q2W	Drug: LBL-033 for Injection; Initial dose - MTD; Q2W; intravenous infusion; Other Names: LBL-033

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum serum concentration	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	After taking a single dose, Time to reach maximum plasma concentration	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	The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects	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）	Percentage of participants achieving CR and PR and stable disease (SD).	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）	The period from the participants first achieving CR or PR to disease progression.	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
Objective Response Rate (ORR)	Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response. This Secondary Outcome Measure was used for efficacy observations in Phase I study	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.

Collaborators and Investigators

• Sponsor: Nanjing Leads Biolabs Co.,Ltd
• Investigators: Principal Investigator: jihong liu, Sun Yat-Sen University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Actual): April 3, 2025
• Study Completion (Actual): April 3, 2025

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: March 19, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: LBL-033-CN001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No