Status:
RECRUITING
Phase I Study of HSK41959 in Solid Tumors With MTAP Deletion
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 meta...
Detailed Description
The study will contain two phases: Phase Ia is dose escalation phase and Phase Ib is dose expansion phase. Phase Ia will contain two part: Dose Escalation Part (Part A) and Extension Part (Part B). P...
Eligibility Criteria
Inclusion
- Age ≥ 18 years，Male and female patients, at time of signing informed consent form (ICF).
- ECOG performance status 0-1.
- 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).
- Homozygous deletion of the MTAP gene detected in tumor tissue confirmed prior to the administration of HSK41959.
- Measurable disease by RECIST 1.1 criteria.
- Adequate hematologic, hepatic, and renal function.
Exclusion
- Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
- The presence of unstable, clinically symptomatic central nervous system metastases or leptomeningeal metastases.
- 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.
- Treatment with any of the following:
- Prior treatment with anti-tumor drug within 4 weeks or approximately 5 × t1/2 prior to the first dose of HSK41959, whichever is shorter; Prior treatment with nitrosourea or mitomycin C within 6 weeks prior to the first dose of HSK41959; Prior treatment with palliative radiotherapy or anti-tumor herbs within 2 weeks prior to the first dose of HSK41959; Prior treatment with radiotherapy, electric field therapy, or other anti-tumor therapies within 4 weeks prior to the first dose of HSK41959.
- 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 HSK41959.
- Any thromboembolic events within 6 months prior to the first dose of HSK41959; 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.
- Any unstable systemic disease, e.g. severe metabolic disease: liver cirrhosis, renal failure, or uremia.
- Patient with cognitive dysfunction, or history of mental illness, other uncontrolled comorbidities, alcohol dependence, hormone dependence or drug abuse.
- Other protocol-defined Inclusion/Exclusion criteria apply
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2028
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT06968572
Start Date
April 11 2025
End Date
May 8 2028
Last Update
May 13 2025
Active Locations (3)
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1
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
2
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
3
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120