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Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas

NCT02900716 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2020-11-27

No results posted yet for this study

Summary

This study will evaluate the safety, antitumor activity and preliminary pharmacokinetics of an investigational drug product, DTRMWXHS-12, in patients with chronic lymphocytic leukemia or other B-cell lymphomas. DTRMWXHS-12 will be evaluated as a single agent, and in combination.

This study will be conducted in two parts: phase Ia and Ib. Both parts will explore escalating doses of DTRMWXHS-12. The phase Ia study will evaluate DTRMWXHS-12 monotherapy. The phase Ib study will evaluate DTRMWXHS-12 combinations.

Conditions

Interventions

DRUG

DTRMWXHS-12

DTRMWXHS-12

DRUG

DTRM-505

DTRMWXHS-12 and everolimus

DRUG

DTRM-555

DTRMWXHS-12 and everolimus and pomalidomide

Sponsors & Collaborators

  • Zhejiang DTRM Biopharma

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-11-23
Completion
2020-11-23

Countries

  • United States

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 NCT02900716 on ClinicalTrials.gov