Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation (NCT07158710) | Clinical Trial Compass
RecruitingPhase 1
Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation
China159 participantsStarted 2025-08-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥6 and \<18 years.
✓. Karnofsky/Lansky Performance Status \>60.
✓. Life expectancy ≥ 3 months.
✓. 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.
✓. Positive BRAF V600 mutation result confirmed prior to the administration of HSK42360.
✓. Patients will provide blood or tumor sample according to their own willingness.
✓. Measurable disease by RANO criteria.
✓. Patients with inactive CNS lesions, or patients treated with ≤5mg/day corticosteroid and without convulsion for ≥2 weeks.
Exclusion criteria
✕. Patients with NF1 mutation.
✕. 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.
✕. Uncontrollable pleural effusion, ascites, or pericardial effusion per protocol.
. 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.
✕. Any disease which would preclude drug absorption, metabolism or pharmacokinetics, eg. active peptic ulcer or chronic gastroesophageal reflux disease.
✕. 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.
✕. Any thromboembolic events within 6 months prior to the first dose of HSK42360; any familial or aquired thrombophilia.