A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT07709000
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Chronic Lymphocytic Leukaemia
  • Hematologic Malignancies
  • Small Lymphocytic Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MK-1045 — BIOLOGICAL
    Intravenous (IV) infusion
  • Acetaminophen (or similar antipyretic) — DRUG
    Oral administration as a premedication
  • Diphenhydramine (or similar antihistamine) — DRUG
    Per approved product label as a premedication
  • Dexamethasone — DRUG
    IV administration as a premedication
  • Tocilizumab — BIOLOGICAL
    IV administration as a rescue medication
  • Tocilizumab biosimilar — BIOLOGICAL
    IV administration as a rescue medication
  • Siltuximab — BIOLOGICAL
    IV administration as a rescue medication

Study Details

Researchers are looking for new ways to treat people with B-cell cancers. In this trial, researchers will look at chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). These are blood cancers that affect B-cells in the blood, bone marrow, or lymph nodes. The goals of this trial are to learn about: * The safety of MK-1045 and if participants tolerate it. Tolerate means participants will receive trial treatment unless they need to stop treatment due to health problems. * The number of participants who respond. Respond means the number of cancer cells goes down or signs of cancer go away.

Key Dates

First listed
Jul 16, 2026
Start date
Aug 21, 2026
Status verified
Jul 2026
Primary completion
Nov 16, 2033
Completion
Nov 16, 2033

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Finding
    Participants will receive a step-up dosing regimen of MK-1045. During Cycle 1, participants will receive priming dose 1 of 1 mg MK-1045 on Day 1, priming dose 2 of 5 mg MK-1045 on Day 4, intermediate dose of 20 mg MK-1045 on Day 8, and then weekly (QW) target dose of 40-90 mg MK-1045 thereafter for up to approximately 2 years. At the discretion of physician investigator and after Sponsor consultation, participants who receive at least 3, 4-week treatment cycles and achieve a complete response may switch to an every two-weeks (Q2W) dosing regimen.
  • Experimental: Part 2: Dose Expansion
    Participants will receive MK-1045 QW at the recommended dose determined in Part 1 for up to approximately 2 years. At the discretion of physician investigator and after Sponsor consultation, participants who receive at least 3, 4-week treatment cycles and achieve a complete response may switch to a Q2W dosing regimen.

Primary Outcome Measure

Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT) [ Time Frame: Up to approximately 29 days ]

Related Studies