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MK-1045

Phase 2

Chronic Lymphocytic Leukaemia | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jul 20, 2026

Success Probability
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Market & Valuation
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Trial Design
CONTROLLED
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical trial landscape

MK-1045 · 6 trials · 11 indications

Phase 2 3Phase 1 3
NCT07709000A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)Chronic Lymphocytic Leukaemia
NOT YET_RECRUITING60 Analytics
NCT07634471A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)Follicular Lymphoma
RECRUITING960 Analytics
NCT07570173A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)B-cell Acute Lymphoblastic Leukemia
RECRUITING340 Analytics
PHASE2NOT YET_RECRUITING
A Clinical Trial of MK-1045 in People With B-cell Cancer (MK-1045-006)
Chronic Lymphocytic LeukaemiaUnlock trial analytics
PHASE2RECRUITING
A Clinical Trial of MK-1045 and Rituximab in People With Follicular Lymphoma (MK-1045-007)
Follicular LymphomaUnlock trial analytics
PHASE2RECRUITING
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic LeukemiaUnlock trial analytics
Study Endpoints
Primary Endpoints
Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT)
Up to approximately 29 days

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.

Cohort A Part 1: Number of Participants Who Experience an AE
Up to approximately 27 months

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.

Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 24 months

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.

Cohort A Parts 1 and 2: Objective Response Rate (ORR)
Up to approximately 66 months

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).

Part 1: Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 15 months

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.

Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 12 months

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.

Part 1: Number of Participants Who Experience Dose Limiting Toxicity (DLT)
Up to approximately 36 days

DLT will be defined as any drug-related AE observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next cycle.

Part 1: Complete Response (CR) Rate
Up to approximately 60 months

For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) per Lugano response criteria. CR rate is defined as the percentage of participants who experience a CR. The CR rate as assessed by physician investigator will be presented.

Part 2: Progression-Free Survival (PFS)
Up to approximately 63 months

PFS is defined as the time from randomization to the first documented disease progression per Lugano response criteria by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first.

Percentage of Participants with Complete Remission (CR) in Study Part 1 and Part 2
3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

CR is defined as: * No circulating lymphoblasts * Extramedullary disease negative * Trilineage hematopoiesis (TLH) and \<5% leukemic blasts * Absolute neutrophil count (ANC) ≥1000/μL * Platelets ≥100,000/μL * No platelet transfusions in the last 7 days * No administration of short-acting granulocyte colony-stimulating factor (G-CSF) and long-acting G-CSF in the last 3 and 14 days, respectively

Percentage of Participants Who Experience an Adverse Event (AE) in Study Part 1
3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

An AE is 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. The percentage of participants with at least 1 AE will be presented.

Percentage of Participants Who Discontinue Study Intervention Due to an AE in Study Part 1
3 treatment cycles (up to approximately 126 days; each cycle is up to 42 days; cycle lengths vary between cycle and arm)

An AE is 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. The percentage of participants who discontinue study intervention due to an AE will be presented.

Overall Survival (OS) in Study Part 2
Up to approximately 7 years

OS is the time from randomization to death due to any cause.

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 44 months

An AE is 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. The number of participants who experience an AE will be reported.

Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 12 months

An AE is 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. The number of participants who discontinue study treatment due to an AE will be reported.

Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT)
Up to approximately 28 Days

DLT will be defined as any drug-related AE observed during the DLT evaluation period (up to 28 days) that results in a change to a given dose or a delay in initiating the next treatment.

Arms 1 and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central review (BICR)
Up to approximately 44 months

ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). In Arms 1 and 4, the percentage of participants who experience CR or PR as assessed by BICR will be presented.

Arm 2: ORR per Lugano Response Criteria as assessed by Investigator
Up to approximately 44 months

ORR is defined as the percentage of the participants who had complete response (CR) or partial response (PR) and will be evaluated using computed tomography (CT) and positron emission tomography (PET)-CT. Response will be assessed based on the International Working Group Criteria: Lugano Classification (Cheson et al, Journal of Clinical Oncology, 2014). CR is complete metabolic (no/minimal fluorodeoxyglucose \[FDG\] uptake) and radiologic response (target lesions regress to ≤1.5 cm in longest transverse diameter of a lesion) and no new lesions. PR is partial metabolic (moderate/high FDG uptake) and radiologic response (≥50% decrease in sum of product diameters for multiple lesions of up to 6 target measurable nodes and extranodal sites, no increase in lesions, and spleen regressed by \>50% in length beyond normal). In Arm 2, the percentage of participants who experience CR or PR as assessed by the Investigator will be presented.

Part 1: Number of Participants with One or More Adverse Events (AEs)
Up to approximately 12 weeks

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.

Part 1: Number of Participants who Discontinue Study Drug Due to an AE
Up to approximately 4 weeks

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.

Part 2 and Part 3: Number of Participants with One or More AEs
Up to approximately 52 weeks

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.

Part 2 and Part 3: Number of Participants who Discontinue Study Drug Due to an AE
Up to approximately 2 weeks

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.

Number of Participants who Experience a Dose-limiting Toxicity (DLT)
Up to ~28 Days

DLT are any of the following drug related (DR) investigator-assessed adverse events: Grade 4 neutropenia that does not recover to Grade ≤ 2 after more than 5 days of supportive care including granulocyte colony-stimulating factor (G-CSF), or ≥ Grade 3 febrile neutropenia; Grade 4 platelet (PLT) decreased, or Grade 3 PLT decreased with bleeding; Grade 4 anemia. Grade 4 non-hematologic toxicity; Grade 3 non-hematologic toxicity that does not recover to Grade ≤ 2 within 3 days after best supportive care (excluding simple laboratory abnormalities without clinical significance as assessed by the investigator). Participants with ≥ Grade 3 tumor lysis syndrome who recover to ≤ Grade 2 within 14 days after optimal supportive therapy will be excluded from the definition of DLT. A DLT was also any other toxic reactions requiring permanent discontinuation of the study intervention.

Number of Participants who Experience a Serious Adverse Events (SAE)
Up to ~15 months

An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the participant receives the intervention, and congenital abnormalities or birth defects. The number of participants who experience a SAE will be reported.

Number of Participants who Experience a Drug-related Adverse Event (DRAE)
Up to ~15 months

An AE is defined as any untoward medical event that occurs after a participant receives the investigational drug, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A DRAE is defined as an AE definitely related, probably related, or possibly related to the study intervention. The number of participants who have experienced a DRAE will be reported.

Number of Participants who Experience an AE of Grade 3 or higher
Up to ~15 months

An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. AEs are graded on a scale from 1-5 with 1=Mild, 2=Moderate, 3=Severe or medically significant but not immediately life-threatening, 4= Life threatening consequences, and 5=Death due to AE. The number of participants who experience an AE of grade 3 or above will be presented.

Number of Participants who Experience an AE for Each Severity Grade from 1-5
Up to ~15 months

An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. AEs are graded on a scale from 1-5 with 1=Mild, 2=Moderate, 3=Severe or medically significant but not immediately life-threatening, 4= Life threatening consequences, and 5=Death due to AE. The number of participants who experience an AE in each category of AEs from 1-5 will be presented.

Number of Participants who Experience a SAE or Serious Drug-related AE
Up to ~15 months

An SAE refers to an untoward medical occurrence such as death, life-threatening event, permanent or serious disability or loss of function, need for hospitalization or prolongation of hospitalization after the participant receives the study intervention, and congenital abnormalities or birth defects. A drug related SAE is defined as an SAE definitely related, probably related, or possibly related to the study intervention. The number of participants who experience a SAE or a serious drug-related AE will be reported.

Number of Participants who Experience a Dose Modification Due to an AE or DRAE
Up to ~15 months

An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A drug related AE includes AEs definitely related, probably related, and possibly related to the study intervention. The number of participants who experience a dose modification due to an AE or DRAE will be presented.

Number of Participants who Withdraw from the Study due to an AE or DRAE
Up to ~15 months

An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A drug related AE includes AEs definitely related, probably related, and possibly related to the study intervention. The number of participants who discontinue the study due to an AE will be presented.

Number of Participants who Died due to an AE or DRAE
Up to ~15 months

An AE is defined as any untoward medical event that occurs after a participant receives the study intervention, which may be manifested as symptoms, signs, diseases, or laboratory abnormalities, but may not necessarily have a causal relationship with the study intervention. A drug related AE includes AEs definitely related, probably related, and possibly related to the study intervention. The number of participants who died due to an AE or DRAE will be presented.

Secondary Endpoints
Cohort A Part 2: Number of Participants Who Experience an AE
Up to approximately 27 months
Cohort A Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 24 months
Cohort A Parts 1 and 2: Duration of Response (DOR)
Up to approximately 66 months
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingSINGLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part 1: Dose FindingEXPERIMENTALParticipants 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.
Part 2: Dose ExpansionEXPERIMENTALParticipants 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.
Part 1: MK-1045 plus Rituximab (or biosimilar)EXPERIMENTALParticipants will receive escalating doses of MK-1045 (from 2 mg to 90 mg) once weekly (QW) for up to approximately 12 months. Participants will also receive 375 mg/m\^2 rituximab (or biosimilar) once every 4 weeks (Q4W) for up to approximately 6 months.
Part 2: MK-1045 plus Rituximab (or biosimilar)EXPERIMENTALParticipants will receive MK-1045 QW at the dose determined in Part 1 for up to approximately 12 months. Participants will also receive 375 mg/m\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months.
Part 2: Physician's Choice of Chemotherapy plus Rituximab (or biosimilar)EXPERIMENTALParticipants will receive physician's choice of: 90 mg/m\^2 bendamustine on Days 1 and 2 of each 4-week cycle for up to 6 cycles (up to approximately 6 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q4W for up to approximately 6 months OR 750 mg/m\^2 cyclophosphamide, 50 mg/m\^2 doxorubicin, and 1.4 mg/m\^2 vincristine on day 1 of each 3-week cycle (Q3W) and 100 mg/m\^2 prednisone (or prednisolone) once daily on days 1 through 5 Q3W for up to 6 cycles (up to approximately 4 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q3W for up to approximately 4 months OR 750 mg/m\^2 cyclophosphamide and 1.4 mg/m\^2 vincristine Q3W and 40 mg/day prednisone (or prednisolone) once daily on days 1 through 5 of each 3-week cycle for up to 6 cycles (up to approximately 4 months) plus 375 mg/m\^2 rituximab (or biosimilar) Q3W for up to approximately 6 months.
MK-1045 Dose Regimen AEXPERIMENTALParticipants will receive a lower MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.
MK-1045 Dose Regimen BEXPERIMENTALParticipants will receive a larger MK-1045 dose once weekly for up to 13 cycles (two 28-day and eleven 42-day cycles). Participants will have the option to change treatment at the end of Part 1.
BlinatumomabACTIVE_COMPARATORParticipants will receive blinatumomab on days 1, 8, 15, and 22 of each 42-day cycle
Arm 1: Follicular Lymphoma (FL) MK-1045 Monotherapy Dose OptimizationEXPERIMENTALParticipants will receive Dosage A of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
Arm 2: FL MK-1045 Longer Dosing IntervalEXPERIMENTALParticipants will receive Dosage B of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
Arm 3: FL MK-1045 Subcutaneous AdministrationEXPERIMENTALParticipants will receive Dosage C of MK-1045 by subcutaneous (SC) injection for up to approximately 1 year of treatment or until discontinuation.
Arm 4: Diffuse Large B-cell Lymphoma (DLBCL) MK-1045 Monotherapy Dose OptimizationEXPERIMENTALParticipants will receive Dosage D of MK-1045 by Intravenous (IV) infusion for up to approximately 1 year of treatment or until discontinuation.
Part 1 Prime Dose Escalation PanelsEXPERIMENTALParticipants will receive single intravenous (IV) doses of MK-1045 at varying dose levels.
Part 2 Step-up Dose Escalation PanelsEXPERIMENTALParticipants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
Part 3 Dose Expansion Panels (Optional)EXPERIMENTALParticipants will receive 3 step up doses of MK-1045 as a prime, step-up and target dose over a 3-week dosing interval.
MK-1045 Fixed DoseEXPERIMENTALParticipants will receive MK-1045 via intravenous (IV) infusion on Day 1 of each week for 3 consecutive weeks followed by one week off of each four-week cycle for up to 12 months until discontinuation or death.
MK-1045 Step-up DoseEXPERIMENTALParticipants will receive MK-1045 via an IV infusion in a step-up dose with priming once a week (Q1W) for a 3-week cycle for up to 12 months until discontinuation or death.
Interventions
NameTypeDescription
MK-1045BIOLOGICALIntravenous (IV) infusion
Acetaminophen (or similar antipyretic)DRUGOral administration as a premedication
Diphenhydramine (or similar antihistamine)DRUGPer approved product label as a premedication
DexamethasoneDRUGIV administration as a premedication
TocilizumabBIOLOGICALIV administration as a rescue medication
Tocilizumab biosimilarBIOLOGICALIV administration as a rescue medication
SiltuximabBIOLOGICALIV administration as a rescue medication
RituximabBIOLOGICALIV infusion
Rituximab biosimilarBIOLOGICALIV infusion
BendamustineDRUGIV infusion
CyclophosphamideDRUGIV infusion
VincristineDRUGIV infusion
PrednisoneDRUGPer approved product label
PrednisoloneDRUGPer approved product label
Doxorubicin HydrochlorideDRUGIV infusion
BlinatumomabBIOLOGICALIntravenous administration
AcetaminophenDRUGOral administration as a premedication
DiphenhydramineDRUGIntravenous administration as a premedication
AvtozmaDRUGIntravenous administration as a rescue medication
TyenneDRUGIntravenous administration as a rescue medication
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Has histologically confirmed chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) active disease that is relapsed/refractory (r/r) to prior therapy. * Has confirmed CD19-positive disease. * If human immunodeficiency virus (HIV)-positive, has well-controlled HIV ...

Countries:United StatesIsraelSpainTaiwanTurkey (Türkiye)DenmarkJapanNetherlandsArgentinaChinaItalyPolandUnited KingdomAustraliaBelgiumColombiaGeorgiaMoldovaRomaniaThailand
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Recent Changes (Last 90 Days)
LOWJul 20, 2026NCT07363590lastUpdatePostDate: changed
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