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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05779163
Other study ID # LBL-033-CN001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date April 14, 2023
Est. completion date March 31, 2026

Study information

Verified date April 2024
Source Nanjing Leads Biolabs Co.,Ltd
Contact xue kong
Phone 025-83378099-842
Email kongxue@leadsbiolabs.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 468
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 years old when signing the informed consent form; 3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) is 0~1; 4. The expected survival time is at least 12 weeks; 5. According to the evaluation of RECIST 1.1 standard, the subjects enrolled have at least one measurable Target lesion; 6. Subject has adequate organ and bone marrow function,Conforming to laboratory test results: 7. 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. Patients with active infection and currently requiring intravenous anti-infective treatment; 3. Those who have clinically uncontrollable pleural effusion, pericardial effusion , requiring repeated drainage or medical intervention; 4. The patient has a Medical history of immunodeficiency, including HIV antibody positive; 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
LBL-033 for Injection
Initial dose - MTD; Q2W; intravenous infusion

Locations

Country Name City State
China West China Second University Hospital,Sichuan University Chengdu Sichuan
China Fujian Cancer Hospital Fuzhou Fujian
China Sun Yat-sen University Cancer Center Guangzhou Guangdong
China Obstetrics & Gynecology Hospital of Fudan University Shanghai Shanghai
China Liaoning Cancer Hospital & Institute Shenyang Liaoning
China Henan Cancer Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Leads Biolabs Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At the end of Cycle 1(28 days after the first prespecified dose)
Primary 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 At the end of Cycle 1(28 days after the first prespecified dose)
Secondary Cmax Maximum serum concentration 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
Secondary Tmax After taking a single dose, Time to reach maximum plasma concentration 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
Secondary immunogenicity The immunogenicity is evaluated by the incidence of anti-drug antibodies (ADA) and neutralizing antibodies (if applicable) in subjects 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
Secondary Disease Control Rate(DCR) Percentage of participants achieving CR and PR and stable disease (SD). 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
Secondary Duration of Response(DOR) The period from the participants first achieving CR or PR to disease progression. 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
Secondary 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 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.
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