Actively Recruiting
Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-09-08
159
Participants Needed
6
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to less than 18 years.
- Karnofsky/Lansky performance status greater than 60.
- Life expectancy of at least 3 months.
- Recurrent malignant brain tumors confirmed by histology or cytology.
- Disease progression after standard treatment or intolerable treatment.
- Positive BRAF V600 mutation confirmed before treatment.
- Willingness to provide blood or tumor samples.
- Measurable disease by RANO criteria.
- Inactive CNS lesions or treated with 5 mg/day or less corticosteroid without convulsions for at least 2 weeks.
- Adequate blood, liver, and kidney function.
- Agreement to use effective contraception during the study and 90 days after last dose for women of childbearing potential and men.
You will not qualify if you...
- Presence of NF1 mutation.
- Malignant tumor within past 2 years except certain low malignancy tumors.
- Uncontrollable pleural effusion, ascites, or pericardial effusion.
- Recent treatment with anti-tumor drugs or therapies within specified washout periods.
- Unresolved toxicities greater than CTCAE grade 1 from prior therapy except alopecia and certain dermal toxicities.
- Diseases affecting drug absorption or metabolism such as active peptic ulcer or chronic reflux.
- Significant or uncontrolled cardiac disease including specific conditions within 6 months prior to study.
- Recent thromboembolic events or thrombophilia.
- Unstable systemic diseases like severe liver cirrhosis or renal failure.
- Recent treatment with certain enzyme inhibitors or substrates within 14 days prior to study.
- Cognitive dysfunction, mental illness, uncontrolled comorbidities, substance dependencies.
- Recent transplantation or major surgery within specified timeframes.
- History of immunodeficiency including HIV.
- Severe retinal abnormalities or uveitis.
- Active hepatitis B or C infection.
- Allergy to HSK42360 ingredients.
- Participation in other clinical trials within 4 weeks prior to study.
- Positive pregnancy test or breastfeeding.
- Any condition judged by investigator to prevent safe participation.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
2
Department of Neuro-oncology, Cancer Center, Beijing Tiantan Hospital, Capital Medical University,Beijing, China
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
3
The first affiliated hospital of fujian medical university
Fuzhou, Fujian, China, 350200
Actively Recruiting
4
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
5
The Third Bethune Hospital of Jilin University
Changchun, Jilin, China, 130000
Actively Recruiting
6
Fudan University Affiliated Huashan Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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