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

Advanced Malignant Tumors Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05779163
• Other study ID #: LBL-033-CN001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Advanced Malignant Tumors
• Neoplasms

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.