CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 93 target
Drug / intervention
ZG005 +3 morebiological
Likely dose
ZG005 10mg/kgfrom 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/NCT06372626
NCT06372626Phase 2RecruitingOn TrackUpdated 24mo ago

A Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of ZG005 in Combination With Etoposide and Cisplatin in Participants With Advanced Neuroendocrine Carcinoma.

Suzhou Zelgen Biopharmaceuticals Co.,Ltd·interventional·Posted Apr 18, 2024·Updated Jun 14, 2024

In Brief

A Phase 2 clinical trial evaluating ZG005, Etoposide, and 2 other interventions for Neuroendocrine Carcinoma. Currently recruiting, targeting 93 participants across 1 site.

Detailed Summary

The trial is divided into two parts. PART 1 is a dose escalation study of the ZG005 combined with Etoposide and Cisplatin, primarily assessing the tolerability and safety of this combined treatment. PART 2 is a dose expansion study, further evaluating the preliminary efficacy and safety of this combined treatment.

Study Details

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

Timeline

Phase 2Recruiting
20252026
First PostedApr 18, 2024
Enrollment StartMay 30, 2024
Primary CompletionJul 1, 2026
Study CompletionAug 1, 2026
TodayJul 1, 2026
Enrollment to primary: 2.1 yearsPosted 2.2 years ago

Interventions

ZG005biological

ZG005 for dose escalations are set as 10mg/kg, 20mg/kg, and the other doses after discussion. intravenous infusion, once every 3 weeks. ZG005 for dose expansion will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage.

Etoposidedrug

IV infusion

Cisplatindrug

IV infusion

Placebodrug

0.9% Sodium Chloride Injection