Phase I/II Clinical Trial of LBL-015 for Injection

NCT ID: NCT05107011

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-08
• Study Completion Date: 2023-12-05

Brief Summary

A Multicenter, Open-label, Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-015 in Patients With Advanced Malignant Tumors.

Detailed Description

This study is a single-arm, open-label, multi-center, dose-escalation and expansion phase I/II study to evaluate the safety, tolerability, pharmacokinetic characteristics, receptor occupancy, immunogenicity and efficacy of LBL-015 in patients with advanced malignant tumors.About 202 patients with advanced malignant tumor will be enrolled.

The study is divided into Phase I study stage (dose escalation/PK expansion stage) and Phase II study stage (indication expansion stage).

Patients with advanced or metastatic advanced malignant tumor who have failed previous standard treatment, are not suitable for standard treatment or have no standard treatment are included in the phase I study.

After obtaining the RP2D in Phase I study ,Phase II study stage (indication expansion stage) was initiated.

Conditions

Advanced Malignant Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LBL-015

Drug: LBL-015 for Injection，Initial dose - MTD; Q2W

Group Type: EXPERIMENTAL

LBL-015 for Injections

Intervention Type: DRUG

Initial dose - MTD ; Q2W ; intravenous infusion

Interventions

LBL-015 for Injections

Initial dose - MTD ; Q2W ; intravenous infusion

Intervention Type: DRUG

Other Intervention Names

LBL-015

Eligibility Criteria

Inclusion Criteria

1. Agree to follow the trial treatment regimen and visit schedule, voluntarily enroll in the study, and sign the written informed consent form；

2. Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender;

3. Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale；

4. Have a life expectancy of at least 12 weeks；

5. There is adequate organ and bone marrow function,Conforms to laboratory test results;

6. Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.

Exclusion Criteria

1. Received other unapproved investigational drug or treatment within 4 weeks prior to first dose of investigational drug；

2. Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period；

3. Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon；

4. Subjects with an active infection that currently requires intravenous anti infective therapy；

5. History of immunodeficiency, including positive HIV antibody test results；

6. Pregnant or lactating women；

7. The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai East Hospital

OTHER

Sponsor Role: collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: collaborator

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Nanchang University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Bengbu Medical University

OTHER

Sponsor Role: collaborator

Nanjing Leads Biolabs Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jin li

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

LBL-015-CN-001

Identifier Type: -

Identifier Source: org_study_id