Nemtabrutinib for Blood Cancers

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing a new pill called nemtabrutinib for patients with blood cancers that have returned or didn't respond to other treatments. The goal is to find a safe and effective dose of the drug. Nemtabrutinib is a new drug being tested for blood cancers, designed to reduce adverse effects.

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for adults with certain blood cancers like lymphoma and leukemia that have come back or didn't respond to treatment. They must have tried at least two other treatments, be able to take pills, and not be eligible for standard therapies. Pregnant women, those with serious health issues, recent heart attacks, active infections or a history of cancer within the last year (with some exceptions) can't join.

Inclusion Criteria

Signed written informed consent granted prior to initiation of any study-specific procedures

I can take care of myself and am up and about more than half of the day.

I have B-cell lymphoma or leukemia and standard treatments haven’t worked for me.

Exclusion Criteria

I am currently taking specific medications as listed.

Pregnant or breast-feeding women

I have other serious health issues that could make the study drug unsafe for me.

Treatment Details

Interventions

• Nemtabrutinib (BTK Inhibitor)

Trial Overview The study tests Nemtabrutinib tablets in patients with relapsed or refractory hematologic malignancies. It looks at how safe and tolerable the drug is, as well as its effects on the body and how it's processed by measuring various parameters over time without comparing it to another treatment.

Participant Groups

Group I: Phase 2: Expansion Food Effect Cohort I Experimental Treatment 1 Intervention

B-cell Non-Hodgkin's lymphoma (NHL), CLL/SLL and WM participants receive up to 65 mg of nemtabrutinib fasted (1 hour prior to or 2 hours after meal) and non-fasted per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group II: Phase 2: Expansion Cohort H Experimental Treatment 1 Intervention

Waldenström macroglobulinemia (WM) participants who have failed at least 2 prior systemic therapies receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group III: Phase 2: Expansion Cohort G Experimental Treatment 1 Intervention

High-grade B-cell lymphoma (BCL) participants who have failed at least 2 prior systemic therapies and have known MYC and BCL2 and/or BCL6 translocations confirmed by flourescence in situ hybridization (FISH) or overexpression by immunohistochemistry (IHC) receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group IV: Phase 2: Expansion Cohort F Experimental Treatment 1 Intervention

Marginal Zone Lymphoma (MZL) participants who have failed at least 2 prior systemic therapies receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group V: Phase 2: Expansion Cohort E Experimental Treatment 1 Intervention

Mantle Cell Lymphoma (MCL) participants who have failed at least 2 prior systemic therapies receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group VI: Phase 2: Expansion Cohort D Experimental Treatment 1 Intervention

Follicular Lymphoma (FL) participants who have failed at least 2 prior systemic therapies and are histology grade 1, 2, or 3A receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group VII: Phase 2: Expansion Cohort C Experimental Treatment 1 Intervention

Richter's transformation (RT) participants who have failed at least one prior therapy receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group VIII: Phase 2: Expansion Cohort B Experimental Treatment 1 Intervention

R/R CLL/SLL participants who have failed or were intolerant to a BTKi with documentation of the absence of BTK mutation on C481 residue receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until PD, unacceptable AEs, or discontinuation at investigator's discretion (up to approximately 64 months).

Group IX: Phase 2: Expansion Cohort A Experimental Treatment 1 Intervention

Relapsed/Refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL) participants with at least 2 prior systemic therapies and previously treated with a covalent Bruton's tyrosine kinase inhibitor (BTKi) who must have a documented BTK mutation on C481 residue receive up to 65 mg of nemtabrutinib per day orally in each cycle (Cycle length = 28 days) until progressive disease (PD), unacceptable adverse events (AEs), or discontinuation at investigator's discretion (up to approximately 64 months).

Group X: Phase 1: Dose Escalation and Determination of RP2D Experimental Treatment 1 Intervention

Phase I: Dose Escalation and determination of RP2D, multiple dose levels of nemtabrutinib to be evaluated (Up to approximately 22 months).

Who Is Running the Clinical Trial?

ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

Lead Sponsor

Trials

37

Recruited

3,600+

ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

Lead Sponsor

Trials

37

Recruited

3,600+