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

This is a multicenter, open-label phase I/II study, divided into 2 parts: Part 1 involves a dose-escalation study of ZG006 in which the safety and tolerability of ZG006 in patients with advanced small cell lung cancer or neuroendocrine carcinoma are explored. Upon completion of Part 1, investigators and the sponsor will discuss and determine two recommended phase II doses (RP2D) based on safety, preliminary efficacy, and pharmacokinetic results for use in Part 2. Part 2 is a phase II dose-expansion study of ZG006, aiming to investigate the efficacy and safety of ZG006 in patients with Neuroe

Trial Details

NCT ID
NCT06440057
Phase
PHASE1 / PHASE2
Sponsor
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • ZG006
Locations (sample)
  • Beijing, Beijing Municipality, China|39.9075,116.39723

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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