FindTrial
Sign In

A Phase 1b/2 Study to Evaluate the Safety and Efficacy of MK‑1045 Monotherapy or in Combination with Other Anticancer Agents in Participants with Non-Hodgkin Lymphoma

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523005-15-00
Enrollment
58
Registered
2026-05-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-05-29

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

Conditions

Non-Hodgkin Lymphoma

Brief summary

Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT), Arms 1 and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central Review (BICR), Arm 2: ORR per Lugano Response Criteria as assessed by Investigator

Detailed description

Arms 1 and 4: Duration of Response (DOR) per Lugano Response Criteria as assessed by BICR, Arms 2 and 3: DOR per Lugano Response Criteria as assessed by Investigator, Area Under the Concentration-time Curve Measured at Steady State (AUCss) of MK-1045, Trough Concentration (Ctrough) of MK-1045, Maximum Serum Concentration (Cmax) of MK-1045, Arms 1, 2, and 4: Time to Maximum Serum Concentration (Tmax) of MK-1045, Arm 3: Absolute Bioavailability Expressed as a Percentage (F%) of MK-1045, Arm 3: ORR per Lugano Response Criteria as assessed by Investigator

Interventions

DRUGTOCILIZUMAB
DRUGMK-1045

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Number of Participants Who Experience an Adverse Event (AE), Number of Participants Who Discontinue Study Treatment Due to an AE, Arms 2 and 3: Number of Participants Who Experience Dose Limiting Toxicity (DLT), Arms 1 and 4: Objective Response Rate (ORR) per Lugano Response Criteria as assessed by Blinded Independent Central Review (BICR), Arm 2: ORR per Lugano Response Criteria as assessed by Investigator—

Secondary

MeasureTime frame
Arms 1 and 4: Duration of Response (DOR) per Lugano Response Criteria as assessed by BICR, Arms 2 and 3: DOR per Lugano Response Criteria as assessed by Investigator, Area Under the Concentration-time Curve Measured at Steady State (AUCss) of MK-1045, Trough Concentration (Ctrough) of MK-1045, Maximum Serum Concentration (Cmax) of MK-1045, Arms 1, 2, and 4: Time to Maximum Serum Concentration (Tmax) of MK-1045, Arm 3: Absolute Bioavailability Expressed as a Percentage (F%) of MK-1045, Arm 3: ORR per Lugano Response Criteria as assessed by Investigator—

Outcome results

None listed

Source: EU CTIS · Data processed: May 30, 2026