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Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07158710•Haisco Pharmaceutical Group Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥6 and \<18 years.
•2. Karnofsky/Lansky Performance Status \>60.
•3. Life expectancy ≥ 3 months.
•4. Patients with recurrent malignant brain tumors confirmed by histology or cytology, who have failed standard treatment (disease progression after treatment or intolerable treatment); patients who have previously received BRAF and/or MEK inhibitor therapy are allowed to be included in this study.
•5. Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.
•6. Patients will provide blood or tumor sample according to their own willingness.
•7. Measurable disease by RANO criteria.
•8. Patients with inactive CNS lesions, or patients treated with ≤5mg/day corticosteroid and without convulsion for ≥2 weeks.
•9. Adequate hematologic, hepatic, and renal function.
•10. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days after the last dose.

Exclusion Criteria

•1. Patients with NF1 mutation.
•2. malignant tumor within 2 years, with the exception of cutaneous squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, or other tumors with low malignancy.
•3. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
•4. Treatment with any of the following:
•Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1/2 prior to the first dose of HSK42360, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK42360; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK42360; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK42360.
•5. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of starting study treatment, with the exception of alopecia, dermal toxicity, and other toxicity considering no safety risks by investigator.
•6. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, eg. active peptic ulcer or chronic gastroesophageal reflux disease.
•7. Patient who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450 msec; any clinically significant arrhythmia; left ventricular ejection fraction \< 50%; myocardial infarction, unstable angina, or class III/IV cardiac failure by the NYHA that occurred within 6 months prior to the first dose of HSK42360.
•8. Any thromboembolic events within 6 months prior to the first dose of HSK42360; any familial or aquired thrombophilia.
•9. Any unstable systemic disease, eg. severe metabolic disease: liver cirrhosis, renal failure, or uremia.
+10 more criteria

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

Key Dates

Start Date

August 15, 2025

Primary Completion Date

May 23, 2029

Completion Date

December 3, 2029

Last Updated

September 8, 2025

Enrollment

159

ESTIMATED participants

Conditions

Malignant Brain Tumors

Interventions

HSK42360

DRUG

Communication Training for Caregivers In Advanced Care Planning

NCT04171895

Primary Malignant Brain TumorsAdvanced Care Planning

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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