A clinical study of MK-1045 in people with non-Hodgkin lymphoma (MK-1045-008)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Decision date (initial)

2026-05-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2025-523005-15-00

WHO UTN

U1111-1324-8720

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacodynamic, Therapy, Pharmacokinetic, Efficacy

1. Arm 1, 2, and 4: To determine the safety and tolerability of MK-1045 administered IV as monotherapy
2. Arm 3: To determine the safety and tolerability of MK-1045 monotherapy administered as a SC injection
3. Arm 1 and 4: To evaluate ORR of participants treated with MK-1045 administered IV as monotherapy per Lugano Response Criteria as assessed by BICR
4. Arm 2: To evaluate ORR of participants treated with MK-1045 administered IV as monotherapy per Lugano Response Criteria as assessed by investigator or designee.

Secondary objectives 5

1. Arm 1 and 4: To evaluate the efficacy of MK-1045 administered as monotherapy with respect to DOR per Lugano Response Criteria as assessed by BICR
2. Arm 2 and 3: To evaluate the efficacy of MK-1045 administered as monotherapy with respect to DOR per Lugano Response Criteria as assessed by investigator or designee
3. Arm 1, 2, and 4: To assess the PK profile of MK-1045 administered as monotherapy
4. Arm 3: To characterize the PK profile of MK-1045 after SC injection
5. Arm 3: To evaluate ORR of participants treated with MK-1045 administered as a SC injection as monotherapy per Lugano Response Criteria as assessed by investigator or designee

Conditions and MedDRA coding

Non-Hodgkin Lymphoma

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Has disease that has relapsed (disease progression after remission) or is refractory (failure to achieve complete or partial response) to at least 2 prior systemic lines of therapy.
2. Has a histologically confirmed diagnosis of follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL).
3. DLBCL participants only: has progressed after or is ineligible for transplant and chimeric antigen receptor T (cell) (CAR-T) therapy.
4. Has provided tumor tissue sample (archival or newly obtained, if performed per standard of care).
5. Has documented retained expression of cluster of differentiation 19 (CD19) in tumor tissue obtained by biopsy after disease progression on CD19-targeting therapy, if experienced disease progression after prior CD19-targeting therapy.
6. Has well-controlled human immunodeficiency virus (HIV) on antiretroviral therapy if has a history of HIV infection.
7. Has undetectable hepatitis B virus (HBV) viral load and received and will continue to receive HBV antiviral therapy if hepatitis B surface antigen (HBsAg)-positive.
8. Has undetectable hepatitis C virus (HCV) viral load and received HCV antiviral therapy if has a history of HCV infection.
9. Has radiographically measurable disease per Lugano Response Criteria.

Exclusion criteria 14

1. Has received a solid organ transplant.
2. Had or has clinically relevant central nervous system (CNS) diseases.
3. Has a history of serious cardiovascular or cerebrovascular diseases.
4. Had prior allogenic stem cell transplantation with acute graft-versus-host-disease (GVHD); has ongoing evidence of chronic GVHD manifesting as skin involvement, diarrhea, or increased serum bilirubin; or requires systemic immunosuppression for GVHD.
5. Is HIV-infected with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
6. Has received a live or live-attenuated vaccine within 30 days of randomization.
7. Has received prior CAR-T therapy within 3 months before the first dose of the study intervention.
8. Has a known additional malignancy that is progressing or required active treatment within the past 2 years.
9. Has known active CNS lymphoma or involvement.
10. Has active autoimmune disease that required systemic treatment in the past 2 years.
11. Has active infection requiring systemic therapy.
12. Has a history of severe bleeding disorders.
13. Has not recovered from major surgery or has ongoing surgical complications.
14. Has diagnosis of primary mediastinal B-cell lymphoma.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 5

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

Secondary endpoints 8

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Andrew Chow

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Andrew Chow

Third parties 7

Locations

5 EU/EEA countries · 23 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 35 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications