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

NCT05779163 | Completed Phase 1 DMC

• 1 other identifier: LBL-033-CN001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 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.

Conditions

Advanced Malignant Tumors

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

Study Arms (1)

LBL-033

EXPERIMENTAL

LBL-033 for Injection; Initial dose - MTD; Q2W

Drug: LBL-033 for Injection

Interventions

LBL-033 for Injection DRUG

Initial dose - MTD; Q2W; intravenous infusion

Also known as: LBL-033

LBL-033

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Nanjing Leads Biolabs Co.,Ltd: lead

Study Sites (6)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510062, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, 110801, China

Location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200011, China

Location

West China Second University Hospital,Sichuan University

Chengdu, Sichuan, 610044, China

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• jihong liu

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

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: April 3, 2025
• Study Completion: April 3, 2025
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)