NCT04806659

A Phase 1 Study of SH1573 Capsules in Subjects With Refractory or Relapsed Acute Myelogenous Leukemia

A Phase 1, Multicenter, Safety, Pharmacokinetic, and Clinical Activity Study of SH1573 Capsules in Subjects With Refractory or Relapsed Acute Myelogenous Leukemia With an IDH2 Mutation

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (estimated)
• Sponsor: Nanjing Sanhome Pharmaceutical, Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of SH1573 in subjects with advanced relapsed, refractory acute myelogenous leukemia that harbor an IDH2 mutation.

Detailed description

SH1573 is an IDH2 mutation inhibitor. This is a phase 1, open-label, multicenter, single-arm study to evaluate safety, tolerability, PK, PD, and preliminary efficacy of SH1573 capsules in treatment of subjects with advanced relapsed, refractory acute myeloid leukemias (AML) that harbor an IDH2 mutation. The study consists of 2 parts: a dose-escalation part (Phase Ia) and a dose-expansion part (Phase Ib). The dose-escalation part will determine the MTD/R2PD. The dose-expansion part will administer the MTD/RP2D to subjects with mIDH2-positive AML.

Conditions

• Acute Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	SH1573 Capsules	Patients from each cohort will be administered SH1573 capsules every day of 28-day treatment cycles until disease progression or unacceptable toxicities.

Timeline

• Start date: 2020-08-04
• Primary completion: 2023-08-31
• Completion: 2023-12-31
• First posted: 2021-03-19
• Last updated: 2021-03-19

Locations

2 sites across 1 country: China