Evaluating LBL-019 for treating advanced malignant tumors

A Multicenter, Open Phase I/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of LBL-019 Monotherapy or Combination Anti-PD-1 Antibody in Patients With Advanced Malignant Tumors

This study is testing a new treatment called LBL-019, alone and with another drug, 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: 486 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Nanjing Leads Biolabs Co.,Ltd (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 6 sites (Fuzhou, Fujian and 5 other locations)
• Trial ID: NCT05223231 on ClinicalTrials.gov

What this trial studies

This phase I/II trial aims to assess the safety, tolerance, pharmacokinetics, receptor occupancy, immunogenicity, and effectiveness of LBL-019, both as a monotherapy and in combination with an anti-PD-1 antibody, in patients with advanced malignant tumors. The study will enroll approximately 244-486 subjects and is divided into two phases: Phase I focuses on dose escalation for both single and combination therapies, while Phase II involves dose expansion for the same treatments. Participants will be closely monitored for their response to the therapies and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced malignant tumors who have failed previous standard treatments.

Not a fit: Patients who have recently undergone other anti-tumor treatments or are pregnant or breastfeeding 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 exhausted standard treatment options.

How similar studies have performed: While this approach is being explored in this trial, similar studies involving anti-PD-1 therapies have shown promise in treating various cancers.

Eligibility criteria

Inclusion Criteria:

1.Agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form;

2.18-75 years old (including boundary value), no gender limit;

3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage;

4.The expected survival time is at least 12 weeks;

Exclusion Criteria:

1. Have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time；
2. Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug;
3. Women who are pregnant or breastfeeding;
4. The investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study

Where this trial is running

Fuzhou, Fujian and 5 other locations

• Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
• Union hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• The first affiliated hospital with Nanjing medical university — Nanjing, Jiangsu, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (Recruiting)

Study contacts

• Principal investigator: caicun zhou — Shanghai Pulmonary Hospital, Shanghai, China
• Study coordinator: ling zang

Conditions Advanced Malignant Tumors