This is a multicenter, open-label Phase I/II study consisting of two parts:
Part 1 is a Phase I dose-escalation study of ZG006, aimed at evaluating the safety and tolerability of ZG006 in Participants with advanced small-cell lung cancer or neuroendocrine carcinoma. Upon completion of Part 1, the investigators and sponsor will jointly determine two preliminary recommended Phase II doses for Part 2, based on the available safety, preliminary efficacy, and pharmacokinetic data.
Part 2 is a Phase II dose-expansion study of ZG006, designed to explore and confirm the efficacy and safety of ZG006 monotherapy in advanced small-cell lung cancer.
Fully understand the study and voluntarily sign the informed consent form;
Male or female 18~75 years of age;
Eastern Cooperative Oncology Group(ECOG) Performance Status of 0 or 1;
Life expectancy ≥ 3 months;
Participants were deemed unsuitable for participating in the study by the investigator for any reason.
Parallel
ZG006
Biological/VaccineZG006 will be administered as an intravenous (IV) infusion.
Objective response rate (ORR)
ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response(PR) based on RECIST 1.1 criteria.
Number of participants with adverse events (AEs)
The types and frequencies of adverse events (AEs) evaluated according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
Number of participants with serious adverse events (SAEs)
Duration of response (DOR)
DOR is defined as the time from first evidence of response (CR or PR per RECIST 1.1) to earlier date of disease progression or death due to any cause
Disease control rate (DCR)
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