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

StatusRecruiting
PhasePhase 1/2
Started

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Trial flagged as At Risk
Primary completion moved at least 11 months later Apr 2026 → Apr 2027
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Record History

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  1. Primary and study completion pushed from Apr 2026 to Apr 2027
    • Primary endpoint(s) modified
    • Eligibility criteria expanded, about 6 words
  2. Enrollment target: 105 to 265
    • Eligibility criteria expanded, about 56 words
    v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 2024 to Sep 2, 2024
    • Site details revised
    v3
  4. Start date: Apr 2024 to Jun 2024v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT06283719
Lead Sponsor Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Conditions
(from sponsor)		 Small Cell Lung Cancer, Neuroendocrine Cancer
Related terms Carcinoma, Neuroendocrine, Small Cell Lung Carcinoma
Enrollment 265 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov