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

NCT07158710 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-09-08

No results posted yet for this study

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

DRUG

HSK42360

Oral administration, QD/BID

Sponsors & Collaborators

  • Haisco Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-15
Primary Completion
2029-05-23
Completion
2029-12-03

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07158710 on ClinicalTrials.gov