Actively Recruiting
Phase I Study of HSK41959 in Solid Tumors With MTAP Deletion
Led by Haisco Pharmaceutical Group Co., Ltd. · Updated on 2025-05-13
245
Participants Needed
3
Research Sites
160 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 HSK41959 when given orally in patients with MTAP Deletion locally advanced or metastatic Solid Tumors.
CONDITIONS
Official Title
Phase I Study of HSK41959 in Solid Tumors With MTAP Deletion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Male and female patients
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Locally advanced or metastatic solid tumors confirmed by histology or cytology
- Failure of standard treatment due to disease progression or intolerance
- Homozygous deletion of the MTAP gene in tumor tissue confirmed before treatment
- Measurable disease according to RECIST 1.1 criteria
- Adequate blood, liver, and kidney function
You will not qualify if you...
- Prior treatment with PRMT5 or MAT2A inhibitor therapy
- Unstable or clinically symptomatic central nervous system metastases or leptomeningeal metastases
- Malignant tumor within the past 2 years except certain low malignancy tumors
- Uncontrollable pleural effusion, ascites, or pericardial effusion
- Recent anti-tumor treatment within 2 to 6 weeks depending on therapy type before starting study drug
- 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 gastroesophageal reflux disease
- Significant or uncontrolled cardiac disease including specific QTc intervals, arrhythmias, low ejection fraction, recent serious cardiac events
- Thromboembolic events within 6 months or thrombophilia
- Uncontrolled hypertension, diabetes, seizures, chronic lung diseases, Parkinson's disease, active bleeding, or systemic infection
- Severe metabolic diseases like liver cirrhosis, renal failure, or uremia
- Cognitive dysfunction, mental illness, uncontrolled comorbidities, alcohol or drug dependence
- Other protocol-defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Not Yet Recruiting
2
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
3
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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