RecruitingPhase 1NCT07158710

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


Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Enrollment

159 participants

Start Date

Aug 15, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study tests a new drug called HSK42360 for children and teenagers with recurrent malignant brain tumors (such as gliomas) that have a specific genetic mutation called BRAF V600. This mutation is found in a subset of brain tumors and makes them potentially vulnerable to targeted therapy. **You may be eligible if...** - You are between 6 and 17 years old - You have a confirmed recurrent malignant brain tumor with a BRAF V600 mutation - Your tumor has failed to respond to or has progressed after standard treatment - You have adequate kidney, liver, and blood function - Your overall performance is relatively good (Karnofsky/Lansky score above 60) **You may NOT be eligible if...** - You have an NF1 gene mutation - You have had another malignant tumor within the past 2 years (some skin cancers may be exempt) - You have active, uncontrolled brain swelling or frequent seizures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHSK42360

Oral administration, QD/BID


Locations(6)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Department of Neuro-oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University,Beijing, China

Beijing, Beijing Municipality, China

The first affiliated hospital of fujian medical university

Fuzhou, Fujian, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

The Third Bethune Hospital of Jilin University

Changchun, Jilin, China

Fudan University Affiliated Huashan Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT07158710


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