NCT07158710

Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation

A Phase I, Open-label, Dose-escalation and Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HSK42360 in Pediatric Patients With BRAF V600-Mutant Malignant Brain Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 159 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK of HSK42360 when given orally in pediatric patients with active BRAF V600 mutation recurrent malignant brain tumors.

Conditions

• Malignant Brain Tumors

Interventions

Type	Name	Description
DRUG	HSK42360	Oral administration, QD/BID

Timeline

• Start date: 2025-08-15
• Primary completion: 2029-05-23
• Completion: 2029-12-03
• First posted: 2025-09-08
• Last updated: 2025-09-08

Locations

6 sites across 1 country: China