A Phase Ib/II Clinical Trial of LBL-007 Combined With Tislelizumab in the Treatment of Malignant Tumors

March 27, 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 Tislelizumab in the Treatment of Malignancies

This trial is an open and multicenter 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 is an open, multicenter Phase Ib/II clinical trial of LBL-007 combined with Tislelizumab in the treatment of malignant tumors，which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

The study was divided into two phases: Phase Ib (Part A): Dose escalation and PK expansion; Phase II includes: Part B, Part C, Part D, Part E, Part F, Part G, Part H. Part B ~ Part H will be designed and conducted based on the safety , tolerability and PK analysis of the Part A Study Part, after RP2D is determined, will be used for Part B ~ Part H cohort. Approximately 250-490 subjects will be enrolled (Specific sample size shall be subject to actual occurrence)

Study Type

Interventional

Enrollment (Estimated)

490

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
      • Hefei, Anhui, China, 230031
    • Fujian
      • Fuzhou, Fujian, China, 350001
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • Sun Yat-sen Memorial Hospital,Sun Yat-sen University
        • Contact:
      • Huizhou, Guangdong, China, 516000
      • Jiangmen, Guangdong, China, 440700
      • Maoming, Guangdong, China, 525000
      • Zhanjiang, Guangdong, China, 524000
        • Not yet recruiting
        • Central People's Hospital of Zhanjinag
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
      • Nanning, Guangxi, China, 530000
      • Yulin, Guangxi, China, 537000
    • Hainan
      • Haikou, Hainan, China, 570000
        • Recruiting
        • The Second Affiliated Hospital of Hainan Medical University
        • Contact:
    • Hangzhou
      • Hangzhou, Hangzhou, China, 310000
    • Hubei
      • Wuhan, Hubei, China, 430000
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
    • Shanghai
      • Shanghai, Shanghai, China, 201100
    • Sichuan
      • Chengdu, Sichuan, China, 610041

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. According to the evaluation criteria for the efficacy of solid tumors (RECIST 1.1), the subjects enrolled have at least one measurable tumor lesion;
  6. Subject has adequate organ and bone marrow function
  7. Males with fertility and females of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine device, various hormonal contraception, correct use of contraception from the signing of the informed consent form to 6 months after the last administration of the trial drug 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 clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
  3. Women during pregnancy or lactation;
  4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
  5. Patients with history of severe cardiovascular and cerebrovascular diseases.
  6. Patients with active infection and currently requiring intravenous anti-infective treatment

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 & Tislelizumab
LBL-007 Injection; dose A or dose B; Q3W
Drug: LBL-007 Injection
Initial dose - MTD; Q3W; intravenous infusion
Other Names:
  • LBL-007
Drug: Tislelizumab Injection
Initial dose; Q3W; intravenous infusion
Other Names:
  • Tislelizumab
Drug: Cisplatin Injection
Initial dose；Q3W; intravenous infusion
Other Names:
  • Cisplatin
Drug: Gemcitabine Hydrochloride for Injection
Initial dose；Q3W; intravenous infusion
Other Names:
  • Gemcitabine Hydrochloride
Drug: Docetaxel injection
Initial dose；Q3W; intravenous infusion
Other Names:
  • Docetaxel

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
ORR (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST), refers to the percentage of study subjects who achieve a complete response or partial 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
Dose-limiting toxicities（DLT）
Time Frame: DLT is defined as toxicity during the DLT observation period. The duration of DLT observation period is from the first dose to 3 weeks after the first dose
DLT is defined as toxicity during the DLT observation period (3 weeks after the first dose).
DLT is defined as toxicity during the DLT observation period. The duration of DLT observation period is from the first dose to 3 weeks after the first dose
Maximum tolerated dose (MTD)
Time Frame: At the end of Cycle 1 (each cycle is 21days)
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
At the end of Cycle 1 (each cycle is 21days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
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)
Maximum serum concentration
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)
immunogenicity
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 immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
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)
DCR per RECIST 1.1 is defined as the percentage of participants with a best overall response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD).
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)
To measure duration of 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)
Tmax
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)
After taking a single dose, Time to reach maximum plasma concentration
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)

September 1, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

August 24, 2022

First Posted (Actual)

August 26, 2022

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LBL-007-CN-004

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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