A Phase 2, Open-label, Multicenter Study to Determine the Safety, Tolerability, and Efficacy of MK- 1045 in Participants with Hematologic Malignancies

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-522242-49-00

Enrollment

Registered

2026-10-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CLL/SLL

Brief summary

Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT), Cohort A Part 1: Number of Participants Who Experience an Adverse Event (AE), Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE, Cohort A Parts 1 and 2: Objective Response Rate (ORR)

Detailed description

Cohort A Part 2: Number of Participants Who Experience an AE, Cohort A Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE, Cohort A Parts 1 and 2: Duration of Response (DOR), Cohort A Parts 1 and 2: Area Under the Curve at Steady State (AUCss) of MK-1045, Cohort A Parts 1 and 2: Maximum Concentration (Cmax) of MK-1045, Cohort A Parts 1 and 2: Concentration Immediately Before the Next Dose Is Administered (Ctrough) of MK-1045, Cohort A Parts 1 and 2: Percentage of Participants Who Develop Antidrug Antibodies (ADA) to MK-1045, Cohort A Parts 1 and 2: Percentage of Participants Who Develop MK-1045 Neutralizing Antibodies (NAb)

Interventions

DRUGMK-1045

DRUGTOCILIZUMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Cohort A Part 1: Number of Participants Who Experience Dose-Limiting Toxicity (DLT), Cohort A Part 1: Number of Participants Who Experience an Adverse Event (AE), Cohort A Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE, Cohort A Parts 1 and 2: Objective Response Rate (ORR)	—

Secondary

Measure	Time frame
Cohort A Part 2: Number of Participants Who Experience an AE, Cohort A Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE, Cohort A Parts 1 and 2: Duration of Response (DOR), Cohort A Parts 1 and 2: Area Under the Curve at Steady State (AUCss) of MK-1045, Cohort A Parts 1 and 2: Maximum Concentration (Cmax) of MK-1045, Cohort A Parts 1 and 2: Concentration Immediately Before the Next Dose Is Administered (Ctrough) of MK-1045, Cohort A Parts 1 and 2: Percentage of Participants Who Develop Antidrug Antibodies (ADA) to MK-1045, Cohort A Parts 1 and 2: Percentage of Participants Who Develop MK-1045 Neutralizing Antibodies (NAb)	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Oct 17, 2026