Trials / Completed
CompletedNCT02900716
Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas
A Phase Ia/Ib Study of a Novel BTK Inhibitor, DTRMWXHS-12, and Combination Products, DTRM-505 and DTRM-555, in Patients With Chronic Lymphocytic Leukemia or Other B-cell Lymphomas
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Zhejiang DTRM Biopharma · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | DTRMWXHS-12 | DTRMWXHS-12 |
| DRUG | DTRM-505 | DTRMWXHS-12 and everolimus |
| DRUG | DTRM-555 | DTRMWXHS-12 and everolimus and pomalidomide |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2020-11-23
- Completion
- 2020-11-23
- First posted
- 2016-09-14
- Last updated
- 2020-11-27
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02900716. Inclusion in this directory is not an endorsement.