BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma

Phase 1

Completed

• Conditions: Mantle Cell Lymphoma
• Interventions: Drug: DTRMWXHS-12

• Registration Number: NCT03836768
• Lead Sponsor: Zhejiang DTRM Biopharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-11
• Study First Submitted: 2019-01-30
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Primary Completion: 2021-11-17
• Study Completion: 2021-11-17
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-14
• Last Update Posted: 2023-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Treatment	DTRMWXHS-12	DTRMWXHS-12, oral capsule, daily, 28 days as a cycle

Primary Outcome Measures

Name	Time	Method
Safety: Incidence and severity of (serious) adverse events n each patient according to the NCI-CTCAE4.03 grading	Starting from date of first dose up to 35 days after last dose	To monitor AEs and SAEs in each patient according to the NCI-CTCAE4.03 grading criteria by evaluating changes in physical examination, laboratory tests, and 12-lead ECG during the whole study

Secondary Outcome Measures

Name	Time	Method
concentration of drug in plasma	From date of first dose to day 56	concentration of drug in plasma

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, China