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BTK Inhibitor DTRMWXHS-12 in Mantle Cell Lymphoma

NCT03836768 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-02-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

DTRMWXHS-12

DTRMWXHS-12 capsules: 150 mg, 300 mg

Sponsors & Collaborators

  • Zhejiang DTRM Biopharma

    lead INDUSTRY

Principal Investigators

  • Wei He, Ph.D. · Zhejiang DTRM Biopharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-11
Primary Completion
2021-11-17
Completion
2021-11-17
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836768 on ClinicalTrials.gov