CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 130 target
Drug / intervention
ZG005 Powder for Injection +1 moredrug
Likely dose
Donafenib Tosilate Tablets 0.2gfrom 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/NCT06239298
NCT06239298Phase 2RecruitingMonitorUpdated 24mo ago · Completion was 4mo ago
Slow Enrollment
Monitor

A Multi-center, Open, Dose Exploration and Dose Expansion Phase I/II Study of ZG005 Combined With Donafenib Tosilate Tablets in Patients With Advanced Solid Tumor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd·interventional·Posted Feb 2, 2024·Updated Jun 14, 2024

In Brief

A Phase 2 clinical trial evaluating ZG005 Powder for Injection and Donafenib Tosilate Tablets for Solid Tumor. Currently recruiting, targeting 130 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed Summary

This is a Multi-center, Open-labe, Phase I/II Study to evaluate the safety and tolerability of ZG005 Combined With Donafenib in Patients With Advanced Solid Tumor.

Study Details

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

Timeline

Phase 2RecruitingOverdue
202420252026
First PostedFeb 2, 2024
Enrollment StartMay 10, 2024
Primary CompletionMar 1, 2026
Study CompletionMay 1, 2026
TodayJul 1, 2026
Enrollment to primary: 1.8 yearsPosted 2.4 years ago

Interventions

ZG005 Powder for Injectiondrug

intravenous infusion(IV), once every 3 weeks

Donafenib Tosilate Tabletsdrug

The dose groups of Donafenib for dose-exploration stage are set as 0.2g BID, 0.1g BID, and 0.1g QD, oral administration.The dose-expansion stage will commence after the Recommended Phase 2 Dose (RP2D) is determined during the dose-escalation stage