NCT05158491

Safety, Tolerability and Preliminary Efficacy of JK1201I in Patients With SCLC

Safety, Tolerability and Preliminary Efficacy of JK1201I in Patients With Small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 63 (estimated)
• 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, tolerability and primary efficacy of JK-1201I in patients with small cell lung cancer (SCLC)

Detailed description

This study is a multi-center, open labeled, single, -combined, with multiple dose escalation trial. The trial consists of dose escalation phase and dose expansion phase; Dose escalation phase: based on the earlier studies, 3 more patients will be added to the 180mg/m2 dose group. The follow-up dose group will adopt the "3+3" design, with 3-6 subjects in each group; include 3 preset dose levels, 220mg/m2, 260mg/m2 and 300mg/m2, respectively. Each subject will receive only one corresponding dose. After the completion of single dose and 21-day DLT observation period, Safety is assessed by the investigator and sponsor, and if the safety evaluation results is favorable, subject will continue to receive the same level of testing compound. Each patient will receive maximum of 4 cycle of treatments. Dose expansion stage: according to the results of the dose increasing stage, dose groups will be selected for expansion. It is expected that 2 to 3 dose groups will enter the expansion stage, and the total number of participants in each dose group will be 20, and a total of 4 cycles of drug administration will be given to each subject.

Conditions

• Small Cell Lung Cancer (SCLC)

Interventions

Type	Name	Description
DRUG	JK-1201I	JK-1201I will be given every 3 weeks, maximum of 4 treatment cycle.

Timeline

• Start date: 2021-11-11
• Primary completion: 2022-12-31
• Completion: 2023-03-31
• First posted: 2021-12-15
• Last updated: 2022-01-05

Locations

1 site across 1 country: China