BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma

Summary

The Primary Objective is to evaluate the safety and tolerability of the DTRMWXHS-12 capsule in patients with relapsed/refractory MCL and recommend the dose and dosing method (RP2D) used in phase II study. The Secondary Objective is to evaluate the pharmacokinetics (PK) of multiple dose oral administration of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL. The Exploratory Objective is to preliminarily evaluate the efficacy of DTRMWXHS-12 capsule in patients with relapsed/refractory MCL.

Timeline

Start

2019-01-11

Primary completion

2021-11-17

Completion

2021-11-17

Drugs

Indications