Spots Global Cancer Trial Database for A Study to Investigate Safety and Tolerability of SH3765 Tablet in Patients With Advanced Malignant Tumor
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Trial Identification
Brief Title: A Study to Investigate Safety and Tolerability of SH3765 Tablet in Patients With Advanced Malignant Tumor
Official Title: A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3765 Tablet in Patients With Advanced Malignant Tumor
Study ID: NCT05015309
Conditions
Interventions
Study Description
Brief Summary: The primary objective is to determine the safety and tolerability of SH3765 in subjects with advanced malignant tumor by determining the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D). The second objective is to evaluate the PK profile and preliminary efficacy of SH3765 in subjects with advanced malignant tumor.
Detailed Description: This is a Phase I, open-label, multicenter, multidose, two-part study to assess the safety, tolerability, PK and preliminary efficacy of SH3765, a protein arginine methyltransferase 5 (PRMT5) inhibitor, in subjects with advanced malignant tumor including but not limited to solid tumor and non-Hodgkin lymphoma.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China
Contact Details
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