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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522242-49 | Registry Identifier | EU CT | |
| U1111-1322-3169 | Registry Identifier | UTN | |
| MK-1045-006 | Other Identifier | MSD |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose Finding | Experimental | 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. |
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| Part 2: Dose Expansion | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-1045 | Biological | Intravenous (IV) infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT) | DLT will be defined as any drug-related adverse event (AE) observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next dose. | Up to approximately 29 days |
| Cohort A Part 1: Number of Participants Who Experience an AE | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 27 months |
| Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. | Up to approximately 24 months |
| Cohort A Parts 1 and 2: Objective Response Rate (ORR) | ORR is defined as the percentage of participants with complete response (CR), complete response with an incomplete recovery of the participant's bone marrow (CRi), nodular partial response (nPR), or partial response (PR), per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018 as assessed by blinded independent central review (BICR). | Up to approximately 66 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort A Part 2: Number of Participants Who Experience an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. | Up to approximately 27 months |
| Cohort A Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Acetaminophen (or similar antipyretic) | Drug | Oral administration as a premedication |
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| Diphenhydramine (or similar antihistamine) | Drug | Per approved product label as a premedication |
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| Dexamethasone | Drug | IV administration as a premedication |
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| Tocilizumab | Biological | IV administration as a rescue medication |
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| Tocilizumab biosimilar | Biological | IV administration as a rescue medication |
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| Siltuximab | Biological | IV administration as a rescue medication |
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An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. |
| Up to approximately 24 months |
| Cohort A Parts 1 and 2: Duration of Response (DOR) | For participants who demonstrate a CR, CRi, nPR, or PR per iwCLL Criteria 2018 as assessed by BICR, DOR is defined as the time from the first documented evidence of CR, CRi, nPR, or PR until disease progression or death due to any cause, whichever occurs first. | Up to approximately 66 months |
| Cohort A Parts 1 and 2: Area Under the Curve at Steady State (AUCss) of MK-1045 | Blood samples will be collected at designated timepoints to estimate the AUCss of MK-1045. | Predose and at designated time points post-dose (up to approximately 24 months) |
| Cohort A Parts 1 and 2: Maximum Concentration (Cmax) of MK-1045 | Blood samples will be collected at designated timepoints to estimate the Cmax of MK-1045. | Predose and at designated time points post-dose (up to approximately 24 months) |
| Cohort A Parts 1 and 2: Concentration Immediately Before the Next Dose Is Administered (Ctrough) of MK-1045 | Blood samples will be collected at designated timepoints to estimate the Ctrough of MK-1045. | Predose and at designated time points post-dose (up to approximately 24 months) |
| Cohort A Parts 1 and 2: Percentage of Participants Who Develop Antidrug Antibodies (ADA) to MK-1045 | Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable ADAs to MK-1045. | Predose and at designated time points post-dose (up to approximately 24 months) |
| Cohort A Parts 1 and 2: Percentage of Participants Who Develop MK-1045 Neutralizing Antibodies (NAb) | Blood samples collected at designated timepoints will be used to determine the percentage of participants who develop detectable NAbs to MK-1045. | Predose and at designated time points post-dose (up to approximately 24 months) |
| ID | Term |
|---|---|
| D015448 | Leukemia, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D004155 | Diphenhydramine |
| D003907 | Dexamethasone |
| C502936 | tocilizumab |
| C504234 | siltuximab |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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