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

Sponsor
Nanjing Leads Biolabs Co.,Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05042908
Collaborator
(none)
36
Enrollment
3
Locations
1
Arm
22.5
Anticipated Duration (Months)
12
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A phase I clinical study evaluating LBL-003 in the treatment of subjects with advanced solid tumors .

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

This study is a phase I clinical study evaluating LBL-003 monotherapy in patients with advanced solid tumors in dose escalation. The overall design of the study is shown in the figure below. The purpose of the LBL-003 single-dose escalation study in subjects with advanced solid tumors is to evaluate the safety and tolerability of monotherapy to determine the MTD (or MAD) and clinically recommended doses of LBL-003 monotherapy.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
36 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of LBL-003 Injection in Patients With Advanced Malignancies
Actual Study Start Date :
Nov 15, 2021
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: A phase I clinical study evaluating LBL-003 in the treatment of subjects with advanced solid tumors

Drug: LBL-003Injection The test drugLBL-003will be preset with 6 escalation dose levels: dose A, dose B, dose C, dose D and dose E, dose F , administered twice a week.

Drug: LBL-003Injection
LBL-003 was given every two weeks for treatment
Other Names:
  • LBL-003

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of subjcects with adverse events and serious adverse events [All subjects signed the informed consent form to the completion of the follow-up period of drug withdrawal (30±7 days after drug withdrawal or before the start of new anti-tumor therapy) ]]

      The safety profile of LBL-003 will be assessed by monitoring the adverse event(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0

    2. Maximum tolerated dose (MTD) [During the first two Cycles(each cycle is 14 days)]

      MTD is defined as the hightest dose level at which no more than 1 out of 6 subjects experiences a DLT during the first two cycles.

    3. Dose-limiting toxicities [During the first two Cycles(each cycle is 14 days)]

      DLT is defined as a toxicities(adverse event at least possibly related to LBL-003 )occurring during the DLT observation period(the initial 28 days).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Both male and female aged Age ≥ 18 and ≤ 75;

    2. ECOG score: 0-1;

    3. The subjects voluntarily participate in the study, sign the Informed Consent Form, with good compliance, and can cooperate with the follow-up.

    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;Expected survival period ≥ 3 months;

    Exclusion Criteria:

    1. Persons with known hypersensitivity to any of the active ingredients or excipients of LBL-003 Injection or a history of atopic allergic reactions (asthma, rheumatism, eczematous dermatitis) who, in the judgment of the investigator, are not suitable for treatment with the test drug.

    2. Subjects with active central nervous system metastases (regardless of whether they have received treatment), including symptomatic brain metastases, meningeal metastases, or spinal cord compression, but asymptomatic brain metastases (no progression and/or at least 4 weeks after radiotherapy) No neurological symptoms or signs after surgical resection, and dexamethasone or mannitol treatment is not required);

    3. Have received major surgery within 4 weeks before the first administration;

    4. Subjects can not tolerate intravenous administration and have difficulty in venous blood collection (if there is a history of fainting needles and bleeding);

    5. Women during pregnancy or lactation;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Henan Cancer Hospital Zhengzhou Henan China 450003
    2 Hunan Cancer Hospital Changsha Hunan China 410031
    3 Shangdong Cancer Hospital Jinan Shandong China 250117

    Sponsors and Collaborators

    • Nanjing Leads Biolabs Co.,Ltd

    Investigators

    • Principal Investigator: Suxia Luo, Henan Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanjing Leads Biolabs Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT05042908
    Other Study ID Numbers:
    • LBL-003-CN-001
    First Posted:
    Sep 13, 2021
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Dec 10, 2021