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

Nanjing Leads Biolabs

Status and phase: Completed; Phase 1

Conditions: Advanced Malignant Tumor

Treatments: Drug: LBL-003 Injection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05042908

LBL-003-CN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

LBL-003

Experimental group

Description:

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

Treatment:

Drug: LBL-003 Injection