NCT04001075

Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors

A Phase I/IIa, Open-label, Dose-Escalation and Dose Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TJ107 in Chinese Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: TJ Biopharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two-part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of TJ107 in Chinese patients with advanced solid tumors. Approximately a total of 36 \~ 60 patients will be enrolled into the dose escalation cohorts (Part A), and expansion cohorts (Part B).

Conditions

• Advanced Solid Tumord

Interventions

Type	Name	Description
DRUG	TJ107	Patients enrolled in dose escalation part will be given 2 doses (28 days/dose) during the main-treatment period

Timeline

• Start date: 2019-02-25
• Primary completion: 2021-06-30
• Completion: 2021-09-23
• First posted: 2019-06-27
• Last updated: 2024-04-15

Locations

4 sites across 1 country: China