NCT05015309

A Study to Investigate Safety and Tolerability of SH3765 Tablet in Patients With Advanced Malignant Tumor

A Phase I, Open-Label Study to Determine Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of SH3765 Tablet in Patients With Advanced Malignant Tumor

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignant Tumor

Interventions

Type	Name	Description
DRUG	SH3765 tablet	Starting dose 2.5mg, oral administered once daily. If tolerated subsequent cohorts will test increasing doses (5mg, 10mg, 15mg, 20mg, 25mg, 30mg) of SH3765.

Timeline

• Start date: 2021-09-01
• Primary completion: 2023-03-01
• Completion: 2024-09-01
• First posted: 2021-08-20
• Last updated: 2021-08-20

Locations

1 site across 1 country: China