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Safety Study of BTK Inhibitor, DTRMWXHS-12, Used Singly or in Combination, in CLL and B-cell Lymphomas | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT02900716•Zhejiang DTRM Biopharma

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with a diagnosis of chronic lymphocytic leukemia (CLL) or other B-cell neoplasms including small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular B-cell non-Hodgkin's lymphoma (FL) who have no available approved therapies.
•Age \> 18 years.
•Life expectancy greater than 12 weeks.
•Patients must have an ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1.
•Patients must provide written informed consent.
•Ability to swallow and retain capsules.
•Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
•Women of child-bearing potential must have a negative serum or urine pregnancy test.
•Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.
•Men must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female who can become pregnant, for the duration of the study and for at least 4 weeks after the last drug administration, even if they have undergone a successful vasectomy.

Exclusion Criteria

•Received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days or 5 half-lives for targeted therapies prior to this study entry.
•Pregnant or lactating individuals.
•Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
•1. AST or ALT \> 2.5 x ULN
•2. Total bilirubin \> 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 1.5 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility)
•3. Alkaline phosphatase \> 2.5 x ULN
•4. Glomerular filtration rate (GFR) \< 50 mL/min, as assessed using the standard methodology at the investigating center (i.e. Cockroft-Gault), or serum creatinine \> 1.5 x ULN
•INR \> 1.5 or other evidence of impaired hepatic synthesis function.
•Persisting (\> 8 weeks) severe pancytopenia due to hematologic disorder or due to previous therapy rather than disease (ANC \< 0.5 x 109/L or platelets \< 30 x 109/L) - to be confirmed via bone marrow biopsy, as part of normal clinical care, prior to signing of consent.
•Previous allogeneic bone marrow transplant are restricted, unless there is no evidence of acute or chronic graft versus host disease.
+12 more criteria

Locations (6)

Mayo Clinic

Phoenix, Arizona, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Duke University Medical Center

Durham, North Carolina, United States

University of Pennsylvania Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

September 1, 2016

Primary Completion Date

November 23, 2020

Completion Date

November 23, 2020

Last Updated

November 27, 2020

Enrollment

ACTUAL participants

Conditions

Chronic Lymphocytic LeukemiaB-Cell Lymphoma

Interventions

DTRMWXHS-12

DRUG

DTRM-505

DRUG

DTRM-555

DRUG

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NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

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RECRUITINGPHASE1/PHASE2

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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B-cell MalignancyMarginal Zone Lymphoma+7 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

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