Treatment of advanced malignant tumors with LBL-033
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.
This study is testing a new treatment called LBL-033 to see if it can help people with advanced malignant tumors feel better and improve their health.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 468 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanjing Leads Biolabs Co.,Ltd Industry-sponsored |
| Locations | 6 sites (Fuzhou, Fujian and 5 other locations) |
| Trial ID | NCT05779163 on ClinicalTrials.gov |
What this trial studies
This is an open, multicenter Phase I/II clinical trial evaluating LBL-033 for patients with advanced malignant tumors. The study is designed to assess the safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness of the treatment. It consists of a Phase I dose-escalation study followed by a Phase II dose expansion involving patients with MUC16-positive malignancies. Blood samples will be collected from participants to further analyze the treatment's effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with advanced malignant tumors and measurable target lesions.
Not a fit: Patients with ECOG scores greater than 1 or those with a life expectancy of less than 12 weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors.
How similar studies have performed: Other studies have shown promise in treating advanced malignant tumors with similar immunotherapeutic approaches, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Fuzhou, Fujian and 5 other locations
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
- Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
- Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
- Liaoning Cancer Hospital & Institute — Shenyang, Liaoning, China (Recruiting)
- Obstetrics & Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
- West China Second University Hospital,Sichuan University — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: jihong liu — Sun Yat-sen University
- Study coordinator: xue kong
- Email: kongxue@leadsbiolabs.com
- Phone: 025-83378099-842
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.