Overview
An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)
Description
This trial includes two parts: phase Ib and phase II study. Phase Ib is a dose-escalation phase and Phase II is a dose-expansion phase.
Phase Ib program to enroll patients with advanced neuroendocrine carcinoma (NEC) without systemic therapy.
To sequentially evaluate the safety and tolerability of LBL-024 in combination with etoposide and platinum (cisplatin or carboplatin) at different doses by the dose-escalation method.
Phase II program to enroll approximately 50 patients with advanced neuroendocrine carcinoma without systemic treatment.
This trial will enroll 68 patients in Phase Ib and Phase II study.
Eligibility
Inclusion Criteria:
- Subject has voluntarily agreed to participate by giving written informed consent for the trial，and Consent to follow trial treatment and visit schedule
- aged 18-75 years (including borderline values) at the time of signing the informed consent form
- Have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Status Scale
- Have a life expectancy of at least 12 weeks
- Subject has at least one measurable target lesion by RECIST 1.1 criteria
- Fertile men and women of childbearing age are willing to take effective contraceptive measures (including abstinence, intrauterine devices, hormonal contraception, and correct use of condoms) from the signing of the informed consent form to 6 months after the last dose of the investigational drug; women of childbearing age include premenopausal women and women who had menopause less than two years ago. Blood pregnancy test results must be negative for women of childbearing age within 7 days prior to the initial dose of the investigational drug.
Exclusion Criteria:
- Subjects who underwent major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the initial use of the investigational drug, or require elective surgery during the trial period
- Use of immunomodulatory drugs within 14 days prior to the initial use of the investigational drug, including but not limited to thymosin, interleukin, and interferon
- Systemic use of corticosteroidsor other immunosuppressants within 14 days prior to the initial use of the investigational drug;The following conditions are excluded: Treatment with topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term use of glucocorticoids for preventive therapy (e.g., to prevent contrast allergy)
- Subjects with an active infection that currently requires intravenous anti infective therapy
- History of immunodeficiency, including positive HIV antibody test results
- Pregnant or lactating women
- The investigator's assessment that there may be other factors affecting compliance among participants or that some may not be suitable for inclusion in this study.