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A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

Primary Purpose

Advanced Malignant Tumors

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
LBL-033 for Injection
Sponsored by
Nanjing Leads Biolabs Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Malignant Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; Age ≥ 18 years old when signing the informed consent form; The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1; The expected survival time is at least 12 weeks; According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion; Subject has adequate organ and bone marrow function,Conforming to laboratory test results: 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: Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; Patients with active infection and currently requiring intravenous anti-infective treatment; Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention; The patient has a Medical history of immunodeficiency, including HIV antibody positive; Women during pregnancy or lactation; The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.

Sites / Locations

  • Fujian Cancer HospitalRecruiting
  • Sun Yat-sen University Cancer CenterRecruiting
  • Henan Cancer HospitalRecruiting
  • Liaoning Cancer Hospital & Institute
  • Obstetrics & Gynecology Hospital of Fudan UniversityRecruiting
  • West China Second University Hospital,Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LBL-033

Arm Description

LBL-033 for Injection; Initial dose - MTD; Q2W

Outcomes

Primary Outcome Measures

Dose-limiting toxicities(DLT)
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Maximum tolerated dose (MTD)
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

Secondary Outcome Measures

Cmax
Maximum serum concentration
Tmax
After taking a single dose, Time to reach maximum plasma concentration
immunogenicity
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
Disease Control Rate(DCR)
Percentage of participants achieving CR and PR and stable disease (SD).
Duration of Response(DOR)
The period from the participants first achieving CR or PR to disease progression.
Objective Response Rate (ORR)
Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response. This Secondary Outcome Measure was used for efficacy observations in Phase I study

Full Information

First Posted
March 7, 2023
Last Updated
June 5, 2023
Sponsor
Nanjing Leads Biolabs Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05779163
Brief Title
A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors
Official Title
A Multicenter, Open Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of LBL-033 in the Treatment of Patients With Advanced Malignant Tumors.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Leads Biolabs Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.
Detailed Description
This is an open, multicenter Phase I/II clinical trial of LBL-033 in the treatment of patients with advanced malignant tumors,which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness. The trial is divided into 2 parts: Phase 1 and Phase 2 Phase I study: Dose-escalation and PK expansion.The PK expansion study will be judged on the basis of dose escalation data. Phase II study: Dose expansion included 4 cohorts that required patients with MUC16-positive malignancies.Blood samples will be collected from all subjects in this trial. Phase I and Phase II studies are expected to recruit 113-468 patients

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Malignant Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
468 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LBL-033
Arm Type
Experimental
Arm Description
LBL-033 for Injection; Initial dose - MTD; Q2W
Intervention Type
Drug
Intervention Name(s)
LBL-033 for Injection
Other Intervention Name(s)
LBL-033
Intervention Description
Initial dose - MTD; Q2W; intravenous infusion
Primary Outcome Measure Information:
Title
Dose-limiting toxicities(DLT)
Description
DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment.
Time Frame
At the end of Cycle 1(28 days after the first prespecified dose)
Title
Maximum tolerated dose (MTD)
Description
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
Time Frame
At the end of Cycle 1(28 days after the first prespecified dose)
Secondary Outcome Measure Information:
Title
Cmax
Description
Maximum serum concentration
Time Frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Title
Tmax
Description
After taking a single dose, Time to reach maximum plasma concentration
Time Frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Title
immunogenicity
Description
The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects
Time Frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Title
Disease Control Rate(DCR)
Description
Percentage of participants achieving CR and PR and stable disease (SD).
Time Frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Title
Duration of Response(DOR)
Description
The period from the participants first achieving CR or PR to disease progression.
Time Frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy
Title
Objective Response Rate (ORR)
Description
Objective Response Rate (complete response (CR) + partial response (PR)), as assessed by Response Evaluation Criteria in Solid Tumors (RECIST 1.1), refers to the percentage of study subjects who achieve a complete response or partial response. This Secondary Outcome Measure was used for efficacy observations in Phase I study
Time Frame
From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (30 days after drug withdrawal or before the start of new anti-tumor therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Agree to follow the experimental treatment plan and visit plan, join the group voluntarily, and sign a written informed consent form; Age ≥ 18 years old when signing the informed consent form; The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1; The expected survival time is at least 12 weeks; According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion; Subject has adequate organ and bone marrow function,Conforming to laboratory test results: 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: Have received other unmarketed clinical research drugs or treatments within 4 weeks before using the research drug for the first time; Patients with active infection and currently requiring intravenous anti-infective treatment; Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention; The patient has a Medical history of immunodeficiency, including HIV antibody positive; Women during pregnancy or lactation; The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xue kong
Phone
025-83378099-842
Email
kongxue@leadsbiolabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
xue kong
Email
kongxue@leadsbiolabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jihong liu
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xue kong
Phone
025-83378099-842
Email
kongxue@leadsbiolabs.com
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510062
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xue kong
Phone
025-83378099-842
Email
kongxue@leadsbiolabs.com
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xue kong
Phone
025-83378099-842
Email
kongxue@leadsbiolabs.com
Facility Name
Liaoning Cancer Hospital & Institute
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110801
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xue kong
Phone
025-83378099-842
Email
kongxue@leadsbiolabs.com
Facility Name
Obstetrics & Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xue kong
Phone
025-83378099-842
Email
kongxue@leadsbiolabs.com
Facility Name
West China Second University Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xue kong
Phone
025-83378099-842
Email
kongxue@leadsbiolabs.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Phase I/II Clinical Trial of LBL-033 in the Treatment of Advanced Malignant Tumors

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