Clinical trial

A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-024 in Patients With Advanced Malignant Tumors

NCT05170958

Name

LBL-024-CN001

Description

To evaluate the phase I/II clinical study of LBL-024 in the treatment of patients with advanced malignant tumors

Trial arms

Trial start

2022-01-06

Estimated PCD

2024-07-01

Trial end

2025-01-01

Status

Recruiting

Phase

Early phase I

Treatment

LBL-024 for Injection

LBL-024 was given every three weeks for treatment

Arms:

LBL-024

Other names:

LBL-024

Size

370

Primary endpoint

Maximum tolerated dose (MTD)

All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal （Visit 30 days after discontinuation of treatment or withdraw from the visit）

Dose-limiting toxicities（DLT)

Within 3 weeks after receiving the first dose of the test drug

Eligibility criteria

Inclusion Criteria: 1. Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form; 2. 18-75 years old (including boundary value), no gender limit; 3. Subject has adequate organ and bone marrow function，Conforming to laboratory test results: 4. The expected survival time is at least 12 weeks 5. 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. Receiving other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; 2. Brain parenchymal metastases or meningeal metastases with clinical symptoms, which are not suitable for inclusion in the group by the investigator's judgment; 3. Women who are pregnant or breastfeeding; 4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 370, 'type': 'ESTIMATED'}}

Updated at

2024-04-01

1 organization

1 product

1 abstract

1 indication

Organization

Nanjing Leads Biolabs

Product

LBL-024

Indication

Advanced Solid Tumor

Abstract

A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase I/II, first-in-human, open-label, multicenter, dose escalation/expansion study.

Org: Peking University Cancer Hospital & Institute, Henan Cancer Hospital, Fudan University Shanghai Cancer Center, Fujian Provincial Cancer Hospital, Zhejiang Cancer Hospital,