CI

At a glance

ClinicalIndex Comparison Record
Phase 2Active· 725 target
Drug / intervention
JSKN003drug
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/NCT05744427
NCT05744427Phase 2ActiveOn TrackUpdated 4mo ago

Phase I/II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics/Pharmacodynamics, and Antitumor Activity of JSKN003 in Chinese Subjects With Advanced Solid Tumors

Jiangsu Alphamab Biopharmaceuticals Co., Ltd·interventional·Posted Feb 27, 2023·Updated Feb 2, 2026

In Brief

A Phase 2 clinical trial evaluating JSKN003 for Advanced Solid Tumor. Active but no longer recruiting, targeting 725 participants across 34 sites.

Detailed Summary

This is an open, multicenter study of phase I/II in Chinese subjects with unresectable locally advanced/metastatic solid tumors. It is divided into the dose escalation period and the cohort expansion period. A total of 8 dose groups (Q3W on the first day of intravenous administration) were designed in the dose escalation period. The initial dose was 1.0mg/kg administered Q3W, with a DLT observation period of 21 days. In the dose expansion phase, 7 cohorts were established.

Study Details

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

Timeline

Phase 2Active
2024202520262027
First PostedFeb 27, 2023
Enrollment StartMar 15, 2023
Primary CompletionJul 30, 2026
Study CompletionDec 31, 2026
TodayJul 1, 2026
Enrollment to primary: 3.4 yearsPosted 3.3 years agoPrimary completion in 29 days

Interventions

JSKN003drug

JSKN003 should be administered intravenously on the first day of each 3-week cycle.