Actively Recruiting
Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2024-08-05
316
Participants Needed
13
Research Sites
158 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 when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid Tumors.
CONDITIONS
Official Title
Phase I Study of HSK42360 in Solid Tumors With BRAF V600 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing consent
- Male and female patients
- ECOG performance status of 0-1 or Karnofsky Performance Status greater than 60
- Life expectancy of at least 3 months
- Locally advanced or metastatic solid tumors confirmed by histology or cytology
- Disease has progressed after standard treatment or treatment was intolerable
- Positive BRAF V600 mutation confirmed before starting HSK42360
- Willingness to provide blood or tumor samples
- Measurable or non-measurable disease by RECIST 1.1 or RANO criteria
- Brain metastasis patients with inactive CNS lesions or patients treated with 4mg/day corticosteroid or less without convulsions for at least 2 weeks
- Adequate blood, liver, and kidney function
- Women of childbearing potential and men agree to use effective contraception during the study and for 90 days after last dose
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 or therapies within specified timeframes before first HSK42360 dose
- Unresolved toxicities greater than CTCAE grade 1 from prior therapies (excluding alopecia and dermal toxicity)
- Diseases affecting drug absorption or metabolism such as active peptic ulcer or chronic gastroesophageal reflux
- Significant uncontrolled cardiac disease or abnormal heart function
- Thromboembolic events within 6 months or thrombophilia
- Uncontrolled hypertension, diabetes, seizures, COPD, interstitial lung diseases, Parkinson's, active bleeding, or systemic infection
- Severe metabolic diseases like liver cirrhosis, renal failure, or uremia
- Use of certain inhibitors, inducers, or substrates for specific enzymes or transporters within 14 days prior to first dose
- Cognitive dysfunction, mental illness, uncontrolled comorbidities, alcohol or drug dependence
- Recent major surgeries or transplantation within specified timeframes
- History of immunodeficiency including HIV
- Eye diseases above CTCAE grade 1
- Active hepatitis B, hepatitis C, or syphilis infection
- Allergy to HSK42360 or its ingredients
- Participation in other clinical trials within 4 weeks prior to first dose
- Positive pregnancy test or breastfeeding
- Other conditions judged by investigator to prevent safe study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Beijing TianTan Hospital,Capital Medical University
Beijing, Beijing Municipality, China, 100070
Actively Recruiting
3
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
4
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
5
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China, 510145
Actively Recruiting
6
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China, 530012
Actively Recruiting
7
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, China, 450099
Actively Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
9
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Actively Recruiting
10
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
11
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210000
Actively Recruiting
12
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
Actively Recruiting
13
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here