Our hospital is conducting a clinical trial initiated by Nanjing Weilizhibo Biotechnology Co., Ltd. titled "An Open-Label, Multicenter Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of LBL-024 in Combination with Etoposide and Platinum-based Chemotherapy as First-Line Treatment in Advanced Neuroendocrine Carcinoma (NEC) Patients" (Protocol No. LBL-024-CN002).

Investigational Drug

The investigational drug is LBL-024 for injection, a bispecific anti-PD-L1/4-1BB antibody independently developed by Nanjing Weilizhibo Biotechnology Co., Ltd. The objective of the study is to evaluate the safety, tolerability, and efficacy of LBL-024 in combination with etoposide and platinum-based chemotherapy as first-line treatment for patients with advanced neuroendocrine carcinoma.Approximately 20 top-tier hospitals nationwide will participate in this study, with around 68 patients (the specific sample size will depend on actual conditions) taking part in the research. The study has been approved by the National Medical Products Administration (NMPA) and the ethics committee of our hospital.

Main Inclusion Criteria for Participation in This Study

1. Agree to follow the study treatment plan and visit schedule, voluntarily enroll, and provide written informed consent.
2. Age must be between 18 and 75 years old (inclusive) at the time of signing the informed consent form.
3. In Phase II of the study, patients with histologically and/or cytologically confirmed, unresectable locally advanced or metastatic extra-pulmonary neuroendocrine carcinoma (NEC) will be included.
4. Patients who have not received prior systemic treatment for advanced NEC. If the patient has received neoadjuvant or adjuvant treatment and relapsed or metastasized more than 6 months after the last dose, they are eligible for inclusion (except those who have previously received anti-PD(L)-1 antibody therapy).
5. Agree to provide archived tissue or fresh biopsy tumor samples for biomarker testing.

Please Note: Eligibility for enrollment will be determined by the comprehensive examination results and the research physician's evaluation.

Contact Us

If you are interested in participating in this study, please contact us, and the research physician will assess your eligibility based on preliminary evaluation. We will strictly keep your personal information confidential. We welcome your registration and participation.

Add the research physician’s WeChat for preliminary screening.

　　Expert Introduction