Treatment of advanced malignant tumors with LBL-007

A Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LBL-007 in Combination With Toripalimab in the Treatment of Advanced Malignancies

This study is testing a new treatment called LBL-007 for people with advanced cancer who have run out of other options to see if it is safe and effective.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (industry)
• Drugs / interventions: immunotherapy, teriprizumab
• Locations: 14 sites (Bengbu, Anhui and 13 other locations)
• Trial ID: NCT05102006 on ClinicalTrials.gov

What this trial studies

This clinical trial is a single-arm, open-label, multi-center study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and effectiveness of LBL-007 in patients with advanced malignant tumors. The trial consists of two phases: a dose escalation phase (Phase Ib) and an expansion phase (Phase II). In Phase Ib, patients who have no standard treatment options or have failed previous treatments will receive LBL-007 at varying doses, while Phase II will focus on specific advanced cancers using the recommended dose determined from Phase Ib. The treatment regimen involves intravenous infusions every three weeks.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with advanced solid tumors who have either failed standard treatments or have no available standard treatment options.

Not a fit: Patients with early-stage tumors or those who have not yet received standard treatment 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 who have limited or no treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, but the specific combination of LBL-007 and Toripalimab is novel.

Eligibility 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 and ≤ 75 years old when signing the informed consent form, regardless of gender;
3. The Eastern Cooperative Oncology Group's physical status scoring standard (ECOG) PS is 0\~1;
4. The expected survival time is at least 12 weeks;
5. 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. Those who have used anti-LAG-3 antibody immunotherapy in the past;
3. Those who have clinically uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage or medical intervention;
4. History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation, except for those who do not need to use immunosuppressive agents (such as corneal transplantation);
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

Bengbu, Anhui and 13 other locations

• The first affiliated hospital of bengbu medical college — Bengbu, Anhui, China (RECRUITING)
• Chongqing University Three Gorges Hospital — Chongqing, Chongqing, China (RECRUITING)
• The 900 Hospital of the Joint Service Support Force of the People's Liberation Army of China — Fuzhou, Fujian, China (RECRUITING)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)
• The First People's Hospital of Yu Lin — Yulin, Guangxi, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)
• Hubei Cancer Hospital — Wuhan, Hubei, China (RECRUITING)
• Wuhan Union Hospital of china — Wuhan, Hubei, China (RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (RECRUITING)
• Changzhou Cancer Hospital — Changzhou, Jiangsu, China (RECRUITING)
• Shandong UNIVERSITY Cheeloo College of Medicine — Jinan, Shandong, China (RECRUITING)
• Affiliated Hospital of Jining Medical University — Jining, Shandong, China (RECRUITING)
• Linyi Cancer Hospital — Linyi, Shandong, China (RECRUITING)
• Tianjin Medical University Cancer Institute Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Principal investigator: li zhang — Sun Yat-sen University
• Study coordinator: xiaona peng

Conditions: Advanced Solid Tumor