Actively Recruiting
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2026-05-01
159
Participants Needed
2
Research Sites
143 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 and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.
CONDITIONS
Official Title
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Male and female patients
- ECOG performance status 0-1 or Karnofsky score 70 or higher
- Life expectancy of at least 3 months
- Locally advanced or metastatic solid tumors confirmed by histology or cytology
- Disease progression after standard treatment or intolerable treatment
- Previous BRAF and/or MEK inhibitor therapy allowed
- Positive BRAF V600 mutation confirmed before treatment
- Willingness to provide blood or tumor samples
- Measurable or non-measurable disease by RECIST 1.1 or RANO criteria
- Brain metastases or intracranial tumors must have inactive CNS lesions and meet corticosteroid and convulsion criteria
- Adequate blood, liver, and kidney function
- Agreement to use adequate contraception during and for 90 days after study participation for women of childbearing potential and men
You will not qualify if you...
- Malignant tumor within 2 years except certain low malignancy tumors
- Uncontrollable pleural effusion, ascites, or pericardial effusion
- Recent treatment with anti-tumor drugs, nitrosourea, mitomycin C, radiotherapy, electric field therapy, or anti-tumor herbs within specified timeframes before study
- Unresolved toxicities from prior therapy above grade 1 except alopecia and dermal toxicity
- Diseases affecting drug absorption or metabolism such as active peptic ulcer or chronic reflux
- Significant or uncontrolled cardiac diseases including prolonged QTc, arrhythmia, low ejection fraction, recent heart attack, unstable angina, or severe heart failure
- Recent thromboembolic events or thrombophilia
- Uncontrolled hypertension, diabetes, seizures, COPD, pneumonia, fibrosis, Parkinson's, active bleeding, or systemic infection
- Unstable severe metabolic diseases like liver cirrhosis or renal failure
- Recent use of certain enzyme inhibitors or substrates affecting drug metabolism
- Cognitive dysfunction, mental illness, alcohol or drug dependence
- Recent major surgery or transplantation
- History of immunodeficiency or HIV
- Eye diseases above grade 1
- Active hepatitis B or C
- Active syphilis infection
- Allergy to HSK42360-Na components
- Participation in other clinical trials within 4 weeks
- Positive pregnancy test or breastfeeding
- Other conditions that could prevent safe participation or compliance as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing TianTan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
Research Team
L
Lin Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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