NCT03710915

A Study of HG146 Capsule in Chinese Subjects with Relapsed and Refractory Multiple Myeloma

A Phase I Study of Single-centre, Open-label Clinical Trial to Evaluate HG146 Capsule in the Treatment of Relapsed and Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: HitGen Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma.

Detailed description

This study is mainly designed to evaluate the tolerability and safety of HG146 capsule in patients with multiple myeloma. Secondly, to get pharmacokinetic data and preliminary efficacy of HG146 capsule in human. This study adopts the traditional design of "3 + 3" dose escalation. The starting dose is 5 mg and subsequent dose group is respectively for 10, 15 and 20 mg. For each dosing group, subjects are administered orally HG146 every other day for two weeks, followed by one week of rest with 21-day as one treatment cycle. Patients will be treated for 4 cycles or disease progression or unacceptable toxicities, whichever comes first.

Conditions

• Multiple Myeloma
• Relapsed and Refractory Multiple Myeloma

Interventions

Type	Name	Description
DRUG	HG146	HG146 will be administered every other day for 14 days, followed by 1 week off the drug with each treatment cycle of 21-days.

Timeline

• Start date: 2019-01-12
• Primary completion: 2022-09-28
• Completion: 2023-06-28
• First posted: 2018-10-18
• Last updated: 2024-10-10

Locations

1 site across 1 country: China