Phase Ib/II Clinical Study of LBL-007 in Treatment of Advanced Malignant Tumors

March 26, 2024 updated by: Nanjing Leads Biolabs Co.,Ltd

A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Toripalimab in the Treatment of Advanced Malignancies

This trial is a single-arm, open, multi-center phase Ib/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and Effectiveness.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is divided into the combined dose escalation (Phase Ib) and the expansion phase (Phase II), as follows:

  1. In the phase Ib study, it is planned to include patients with advanced malignant tumors who have no standard treatment or who have failed the previous standard treatment or who do not apply standard treatment at this stage. According to the "rolling six design" dose escalation method, the tolerability of LBL-007 200 and 400 mg dose levels was evaluated. Each dose group included 3 to 6 subjects, and the total sample size for stage Ib was about 9-12 (specifically The sample size is subject to actual occurrence). The dosage regimen of LBL-007 is once every 3 weeks (Q3W), intravenous infusion; the dosage regimen of combination drug teriprizumab is 240 mg, once every 3 weeks (Q3W), intravenous Infusion. During the experiment, necessary adjustments can be made to the dosing frequency or incremental group settings based on the PK data and safety data obtained. In this study, every 3 weeks is a dosing cycle, and the DLT observation period is 3 weeks after the first dosing.
  2. According to the LBL-007 global research and development data and the safety, tolerability and PK data of the phase Ib clinical study, the recommended dose of phase II clinical study (RP2D) was obtained for the expansion of target indications, including advanced esophageal squamous cell carcinoma, head Patients with malignant tumors such as cervical squamous cell carcinoma, cervical cancer, and nasopharyngeal carcinoma. During the screening period of this study, subjects need to undergo relevant inspections or observations, and those who meet the screening requirements will enter the treatment period. During the treatment period, all subjects will receive a certain dose of the test drug combined with teriprizumab until intolerable toxicity, disease progression, death, voluntary withdrawal, loss to follow-up, or continuous administration for 2 years ( Whichever occurs first). Subjects will be evaluated for anti-tumor efficacy according to the efficacy evaluation criteria for solid tumors (RECIST V1.1) and immunotherapy solid tumor efficacy evaluation criteria (iRECIST), once every 6 weeks after the first administration, and the frequency will be adjusted after 24 weeks It is once every 9 weeks. All subjects in this study will have a safety follow-up 30 days (+7 days) after the last administration or before starting a new anti-tumor therapy, and then enter the survival follow-up, and will collect whether to accept new anti-tumor therapy and survival information, etc. , Until the subject's death or loss to follow-up or withdrawal of informed consent. In this trial, all subjects in phase Ib/II underwent a sparse blood sampling population PK study; all subjects collected blood samples for the evaluation of LBL-007 immunogenicity; all subjects collected tumor tissue samples for biomarkers For related explorations, some subjects will collect blood samples for explorations related to receptor occupancy.

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • Recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 404000
        • Recruiting
        • Chongqing University Three Gorges Hospital
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
    • Guangxi
      • Yulin, Guangxi, China, 537000
        • Recruiting
        • The First People's Hospital of Yu Lin
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450003
    • Hubei
      • Wuhan, Hubei, China, 430000
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Wuhan Union Hospital of China
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410031
    • Jiangsu
      • Changzhou, Jiangsu, China, 213001
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong UNIVERSITY Cheeloo College of Medicine
        • Contact:
      • Jining, Shandong, China, 272029
        • Recruiting
        • Affiliated Hospital of Jining Medical University
        • Contact:
      • Linyi, Shandong, China, 276000
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form;
  2. Age ≥ 18 and ≤ 75 years old when signing the informed consent form, regardless of gender;
  3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0~1;
  4. The expected survival time is at least 12 weeks;
  5. Males with fertility and females of childbearing age are willing to take effective contraceptive measures From the signing of the informed consent form to within 6 months after the last administration of the trial drug (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception Sets，etc）; Women of childbearing age include pre-menopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 7 days before the first trial drug is administered.

Exclusion Criteria:

  1. Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time;
  2. Those who have used anti-LAG-3 antibody immunotherapy in the past;
  3. Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
  4. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, except for those who do not need to use immunosuppressive agents (such as corneal transplantation);
  5. Women during pregnancy or lactation;
  6. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LBL-007&Toripalimab
LBL-007 Injection; dose A or dose B; Q3W
Drug: LBL-007 Injection
LBL-007 Injection; dose A or dose B; Q3W
Other Names:
  • LBL-007
Drug: Toripalimab Injection
Toripalimab is infused with a fixed dose of 3 mg/kg intravenously every three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
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)
Defined as the percentage of subjects having a Complete Response or Partial Response(ORR, including after immunotherapy complete response (iCR) and partial response (iPR)),will be determined by investigator assessment of radiographic disease assessments per RECIST v1.1. and iRECIST.
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)
Dose-limiting toxicities（DLT）
Time Frame: During the first Cycles(each cycle is 21 days)
DLT is defined as toxicity (at least possible adverse events related to LBL-007) during the DLT observation period (3 weeks after the first dose).
During the first Cycles(each cycle is 21 days)
Maximum tolerated dose (MTD)
Time Frame: During the first Cycles(each cycle is 21 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 cycles.
During the first Cycles(each cycle is 21 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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-007 and Toripalimab will be assessed by monitoring the adverse enent(AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events(NCI CTCAE)v5.0
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)
Disease Control Rate(DCR)
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)
Defined as percentage of participants having CR, PR, iCR, iPR or SD as best on-study response
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)
Duration of Response(DOR)
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)
Defined as the time from earliest date of disease response (CR、PR 、iCR 、iPR) until earliest date of disease progression, as determined by investigator assessment of radiographic disease per RECIST v1.1 and iRECIST, or death from any cause, if occurring sooner than progression.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Leads Biolabs Co.,Ltd

Investigators

  • Principal Investigator: Li Zhang, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 14, 2024

Study Registration Dates

First Submitted

October 20, 2021

First Submitted That Met QC Criteria

October 20, 2021

First Posted (Actual)

November 1, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • LBL-007-CN-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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