NCT04366648

Safety, Tolerability and Pharmacokinetics of Injectable PEG-Irinotecan (JK-1201I) in Patients with Malignant Solid Tumor

Study on the Safety, Tolerability and Pharmacokinetics of Single and Multiple Administration of Injectable PEG-Irinotecan (JK-1201I) in Patients with Malignant Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: JenKem Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to evaluate the safety and tolerability of injectable PEG-Irinotecan in patients with malignant solid tumors

Detailed description

This study is a multicenter, open labeled, positive controlled, single, -combined, with multiple dose escalation trial. The trial consists of 6 drug dose groups, which are 50mg/m2, 75mg/m2, 100mg/m2, 125mg/m2, 150mg/m2 and 180mg/m2 respectively. At each testing dose group, one patient will be treated with HCl-Irinotecan (CPT-11), at dose level of 175mg/m2. The initial dose of 50mg /m2 will be administered once. Starting from the 75mg/m2 dose group, each patient will be given testing drug at least twice. During first and second drug administration, blood samples will be collected for PK characteristics analysis. Patients will be evaluated after every two rounds of drug delivery and preliminary efficacy of testing compound will be determined as PD, SD, CR etc.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	JK-1201I	malignant solid tumor that has been confirmed by histopathology and/or cytology

Timeline

• Start date: 2018-05-04
• Primary completion: 2021-03-31
• Completion: 2021-03-31
• First posted: 2020-04-29
• Last updated: 2024-09-04

Locations

1 site across 1 country: China