Evaluation of LBL-003 Phase I Study in Patients With Advanced Malignancies

NCT ID: NCT05042908

Last Updated: 2024-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-02
• Study Completion Date: 2023-04-10

Brief Summary

This study is a single-arm, dose-escalation phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of LBL-003 injection in patients with advanced malignant tumors.

Detailed Description

The purpose of the single-dose escalation study of LBL-003 in subjects with advanced malignant tumors was to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and to determine the clinically recommended dose of LBL-003 monotherapy.

All subjects in this study underwent pharmacokinetic (PK) and pharmacodynamic (PD) studies. The dosing frequency of LBL-003 is once every 2 weeks (Q2W), and the subsequent dosing frequency is adjusted according to the obtained PK and tolerability results.

This study is expected to enroll 17-36 patients with solid tumors who have no standard treatment or have treatment failure with standard treatment or are not suitable for standard treatment at this stage.

Conditions

Advanced Malignant Tumor

Study Design

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

Study Groups

LBL-003

Drug: LBL-003 injection ; Initial dose - MTD; Q2W

Group Type: EXPERIMENTAL

LBL-003 Injection

Intervention Type: DRUG

LBL-003 was given every two weeks for treatment

Interventions

LBL-003 Injection

LBL-003 was given every two weeks for treatment

Intervention Type: DRUG

Other Intervention Names

LBL-003

Eligibility Criteria

Inclusion Criteria

1. Both male and female aged 18-75 years (including borderline values) at the time of signing the informed consent form;

2. ECOG score: 0-1;

3. Agree to follow the study treatment plan and visit plan, voluntarily enrolls, and signs the written informed consent.

4. Subjects with advanced malignant solid tumors confirmed by histology or cytology have failed the standard treatment or have no standard treatment protocol or are not suitable for standard treatment at this stage.

5. Subjects should have at least one evaluable lesion as defined by RECIST V1.1;

6. Subjects are expected to survive at least 12 weeks;

Exclusion Criteria

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

2. Active hepatitis (hepatitis B or C)；

3. having undergone major surgery or still in the recovery phase of an earlier surgery within 4 weeks before the first administration;

4. Women during pregnancy or lactation;

5. 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

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: collaborator

Hunan Cancer Hospital

OTHER

Sponsor Role: collaborator

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: collaborator

Nanjing Leads Biolabs Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suxia Luo

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Shangdong Cancer Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

LBL-003-CN-001

Identifier Type: -

Identifier Source: org_study_id