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

Sponsor
Nanjing Leads Biolabs Co.,Ltd (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05107011
Collaborator
(none)
202
Enrollment
5
Locations
1
Arm
36.9
Anticipated Duration (Months)
40.4
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A phase I/II clinical study evaluating LBL-015 in the treatment of subjects with advanced solid tumors

Condition or Disease Intervention/Treatment Phase
  • Drug: LBL-015 for Injections
 Phase 1/Phase 2

Detailed Description

This trial is a single-arm, open, multi-center, dose-escalation and extended phase I/II study, aiming to evaluate the safety, tolerability, pharmacokinetic characteristics, and receptor occupancy of LBL-015 in patients with advanced malignant tumors Rate (RO), immunogenicity and effectiveness. Approximately 202 subjects with advanced malignant tumors are planned to be included.

The study is divided into two phases: Phase I (dose escalation/PK expansion phase) and Phase II (indication expansion phase)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
202 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Multi-center, Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti Tumor Activity of LBL-015 in Patients With Advanced Malignant Tumors
Actual Study Start Date :
Nov 5, 2021
Anticipated Primary Completion Date :
Oct 1, 2023
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Evaluation of LBL-015 Phase I/II study in patients with advanced malignancies

Drug: LBL-015 for Injection The test drugLBL-003will be preset with 5 escalation dose levels: dose A , dose B, dose C ,dose D and dose E, administered twice a week.

Drug: LBL-015 for Injections
LBL-015 was given every two weeks for treatment
Other Names:
  • LBL-015

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum tolerated dose (MTD) [28 days after the first dose]

      During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/6 of the study drug within 4 weeks of starting treatment

    2. Dose-limiting toxicities（DLT) [28 days after the first dose]

      During the DLT observation period, the subject has an event that is reasonably related to the test drug (possibly, likely or definitely related)

    Eligibility Criteria

    Criteria

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

    1. Agree to follow the trial treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;

    2. Age ≥18 and ≤75 years old at the time of signing the informed consent form, regardless of gender;

    3. Eastern Cooperative Oncology Group performance status scoring criteria (ECOG) PS of 0 ~ 1 points (see Appendix 1 for criteria);

    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 time, except for the following items:

    2. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;

    3. Patients who have previously received treatment with PD-1/PD-L1 and TGF-β bifunctional antibody drugs or received treatment with PD-1/PD-L1 combined with TGF-β target drugs;

    4. Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before using the study drug for the first time,or required elective surgery during the trial period;

    5. Use of immunomodulatory drugs within 14 days before the first use of study drugs, including but not limited to thymosin, interleukin-2, interferon, etc.;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui China 233000
    2 Henan Cancer Hospital Zhengzhou Henan China 450003
    3 Hunan Cancer Hospital Changsha Hunan China 410031
    4 Shandong Cancer Hospital Jinan Shandong China 250117
    5 Shanghai Oriental Hospital Shanghai Shanghai China 200123

    Sponsors and Collaborators

    • Nanjing Leads Biolabs Co.,Ltd

    Investigators

    • Principal Investigator: Jin li, Shanghai Oriental Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nanjing Leads Biolabs Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT05107011
    Other Study ID Numbers:
    • LBL-015-CN-001
    First Posted:
    Nov 4, 2021
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Sep 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

    Study Results

    No Results Posted as of Dec 10, 2021