Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation (NCT07561554) | Clinical Trial Compass
RecruitingPhase 1
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
China159 participantsStarted 2026-03-06
Plain-language summary
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years#Male and female patients, at time of signing informed consent form (ICF).
✓. ECOG performance status 0-1, or KPS (Karnofsky Performance Status) Score≥70.
✓. Life expectancy ≥ 3 months.
✓. Patients with locally advanced or metastatic solid 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-Na.
✓. Patients will provide blood or tumor sample according to their own willingness.
✓. Measurable or non-measurable disease by RECIST 1.1 or RANO criteria.
✓. Brain metastasis patients with inactive CNS lesions; Original intracranial tumor patient with inactive CNS lesions, or patients treated with ≤4mg/day corticosteroid and without convulsion for ≥2 weeks.
Exclusion criteria
✕. 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, e.g. active peptic ulcer or chronic gastroesophageal reflux disease.
✕. Patients who have clinically significant or uncontrolled cardiac disease, include: QTc interval ≥ 450(male)/470(female) 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-Na.
✕. Any thromboembolic events within 6 months prior to the first dose of HSK42360-Na; any familial or acquired thrombophilia.
✕. Uncontrolled hypertension (systolic pressure≥160mmHg, or diastolic pressure≥100mmHg), diabetes (fasting blood-glucose≥10mmol/L), seizures, chronic obstructive pulmonary disease (COPD), interstitial pneumonia, pulmonary interstitial fibrosis, Parkinson's disease, active bleeding, or systemic active infection.