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Safety and Tolerability of JSKN003 in Chinese Subjects With Advanced Solid Tumors

NCT05744427 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 725

Last updated 2026-02-02

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

JSKN003

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

Sponsors & Collaborators

  • Jiangsu Alphamab Biopharmaceuticals Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jiong Wu · Fudan University

  • Jian Zhang · Fudan University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2026-07-30
Completion
2026-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05744427 on ClinicalTrials.gov