drugset / Trial / NCT02900716
Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-09
- Primary completion
- 2020-11-23
- Completion
- 2020-11-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | DTRMWXHS-12 | Unknown | — | Oral |
| Subject | Everolimus | Small molecule | — | Oral |
| Subject | Pomalidomide | Other / unclassified | — | Oral |