Phase I Study of HSK41959 in Solid Tumors With MTAP Deletion
Trial Parameters
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 metastatic Solid Tumors.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years，Male and female patients, at time of signing informed consent form (ICF). 2. ECOG performance status 0-1. 3. Life expectancy ≥ 3 months. 4. 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). 5. Homozygous deletion of the MTAP gene detected in tumor tissue confirmed prior to the administration of HSK41959. 6. Measurable disease by RECIST 1.1 criteria. 7. Adequate hematologic, hepatic, and renal function. Exclusion Criteria: 1. Prior treatment with a PRMT5 or MAT2A inhibitor therapy. 2. The presence of unstable, clinically symptomatic central nervous system metastases or leptomeningeal metastases. 3. 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. 4. Uncontrollable pleural effus