NCT05107037

A Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQ-B3234 in Patients With Type I Neurofibromatosis

A Phase I Clinical Trial to Evaluate the Tolerability and Pharmacokinetics of TQ-B3234 Capsules in Chinese Patients With Type I Neurofibromatosis (Neurofibromatosis and Malignant Peripheral Nerve Sheath Tumors)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a Phase I clinical trial to evaluate the tolerability and pharmacokinetics of TQ-B3234 capsules in Chinese subjects associated with neurofibromatosis type I (neurofibroma and peripheral malignant neurilemmoma). Two study phases were designed, including (1) dose escalation and (2) cohort expansion. The purpose of this study was to evaluate the tolerance, pharmacokinetic characteristics, efficacy and safety of TQ-B3234 capsule, and to explore the therapeutic biomarkers related to this product.

Conditions

• Type I Neurofibromatosis

Interventions

Type	Name	Description
DRUG	TQ-B3234 capsule	TQ-B3234 is an anti-tumor molecular targeted drug, which is a selective Mitogen-activated protein kinase kinase（MEK）1/2 inhibitor

Timeline

• Start date: 2021-11-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2021-11-04
• Last updated: 2021-11-04

Locations

1 site across 1 country: China