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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05042908
Recruitment Status : Not yet recruiting
First Posted : September 13, 2021
Last Update Posted : September 13, 2021
Information provided by (Responsible Party):
Nanjing Leads Biolabs Co.,Ltd

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
Advanced Solid Tumor Drug: LBL-003Injection 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : October 2021
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023

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: 0.36mg, 6mg, 60mg, 180mg and 600mg, 1200mg ,administered twice a week.
Drug: LBL-003Injection
LBL-003 was given every two weeks for treatment
Other Name: LBL-003

Primary Outcome Measures :
  1. Number of subjcects with adverse events and serious adverse events [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05042908

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Contact: lei liu 025-83378099-828
Contact: Ting Lv 025-83378099-829

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China, Hunan
Hunan Cancer Hospital
Changsha, Hunan, China, 410031
Contact: lei liu    025-83378099-828   
Contact: Ting Lv    025-83378099-829   
China, Shandong
Shangdong Cancer Hospital
Jinan, Shandong, China, 250117
Contact: lei liu    025-83378099-828   
Contact: Ting lv    025-83378099-828   
Sponsors and Collaborators
Nanjing Leads Biolabs Co.,Ltd
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Principal Investigator: Suxia Luo Henan Cancer Hospital
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Responsible Party: Nanjing Leads Biolabs Co.,Ltd Identifier: NCT05042908    
Other Study ID Numbers: LBL-003-CN-001
First Posted: September 13, 2021    Key Record Dates
Last Update Posted: September 13, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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