CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 265 target
Drug / intervention
ZG006biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06283719
NCT06283719Phase 2RecruitingMonitorUpdated 7mo ago · Completion was 3mo ago
Slow Enrollment
Monitor

A Phase I Dose Escalation Study of Tolerability, Safety, Efficacy, and Pharmacokinetics of ZG006 in Participants With Advanced Small Cell Lung Cancer or Neuroendocrine Carcinoma, Followed by a Phase II Dose Expansion Study in Participants With Advanced Small Cell Lung Cancer

Suzhou Zelgen Biopharmaceuticals Co.,Ltd·interventional·Posted Feb 28, 2024·Updated Nov 17, 2025

In Brief

A Phase 2 clinical trial evaluating ZG006 for Small Cell Lung Cancer and Neuroendocrine Cancer. Currently recruiting, targeting 265 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2RecruitingOverdue
20252026
First PostedFeb 28, 2024
Enrollment StartSep 2, 2024
Primary CompletionApr 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.6 yearsPosted 2.3 years ago

Interventions

ZG006biological

ZG006 will be administered as an intravenous (IV) infusion.