Dose Escalation Study of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSuzhou Zelgen Biopharmaceuticals Co.,Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

Participants were deemed unsuitable for participating in the study by the investigator for any reason.

Trial design

Treatments tested in this trial

  • ZG006

Treatment groups

265 Participants
are divided into 2 treatment groups