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

Nanjing Leads Biolabs

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Malignant Tumor

Treatments: Drug: LBL-015 for Injections

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05107011

LBL-015-CN-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

LBL-015

Experimental group

Description:

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

Treatment:

Drug: LBL-015 for Injections