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

Nanjing Leads Biolabs

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Advanced Malignant Tumors

Treatments: Drug: LBL-033 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05779163

LBL-033-CN001

Details and patient eligibility

About

This trial is an open and multicenter phase I/II clinical study, which aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and effectiveness.

Full 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

Enrollment: 468 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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468 participants in 1 patient group

LBL-033

Experimental group

Description:

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

Treatment:

Drug: LBL-033 for Injection