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Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors

Evaluation of LBL-019 Monotherapy or Combined With Anti-PD-1 Antibody in the Treatment of Advanced Malignant Tumors

Recruiting
18-75 years
All
Phase 1/2

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Overview

This trial is a phase I/II study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors.

Description

This trial is a phase I/II study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (RO), immunogenicity and effectiveness of LBL-019 monotherapy or combined with anti-PD-1 antibody in patients with advanced malignant tumors. Approximately 244-486 subjects with advanced malignant tumors will be enrolled.

The study was divided into two phases: Phase I (Part A single therapy dose escalation and Part B combination therapy dose escalation) and Phase II (Part A single therapy dose expansion and Part B combination therapy dose expansion) .

Eligibility

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. previous standard treatment failed, no standard treatment or standard treatment is not
        applicable at this stage;
        4.The expected survival time is at least 12 weeks;
        Exclusion Criteria:
          1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy,
             immunotherapy and other anti-tumor treatments within 4 weeks before using the study
             drug for the first timeļ¼›
          2. Received any other investigational drug or treatment that is not on the market within
             4 weeks prior to the initial use of the investigational drug;
          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

Study details
    Advanced Malignant Tumors

NCT05223231

Nanjing Leads Biolabs Co.,Ltd

29 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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