A clinical study of MK-3120 in people with solid tumors (MK-3120-002)

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]

Trial duration

23 May 2025 → ongoing

Decision date (initial)

2025-05-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-516817-19-00

WHO UTN

U1111-1311-1904

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Pharmacokinetic, Safety, Pharmacogenomic, Pharmacogenetic, Pharmacodynamic, Dose response, Efficacy

To evaluate the safety and tolerability of MK-3120 monotherapy

Secondary objectives 3

1. To evaluate the antitumor activity of MK-3120 as measured by ORR per RECIST 1.1 as assessed by the investigator
2. To evaluate the antitumor activity of MK-3120 as assessed by the investigator and measured by DOR, PFS, and OS
3. To evaluate the PK of MK-3120 administered as monotherapy

Conditions and MedDRA coding

Advanced/metastatic solid tumor disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Has a confirmed advanced (unresectable and/or metastatic) solid tumor and has received or been intolerant to all available treatments
2. If human immunodeficiency virus (HIV) positive, has well controlled HIV on antiretroviral therapy (ART)
3. If hepatitis B surface antigen (HBsAg) positive, must have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
4. If hepatitis C virus (HCV) infected, must have undetectable HCV viral load

Exclusion criteria 10

1. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
2. Has uncontrolled significant cardiovascular disease or cerebrovascular disease
3. Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
4. Has pleural effusion, ascites, and/or pericardial effusion that are symptomatic or require repeated drainage
5. Is HIV-positive and has a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
6. Known additional malignancy that is progressing or has required active treatment within the past 2 years
7. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
8. Active infection requiring systemic therapy, with exceptions
9. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
10. Has HBV or HCV infection

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Number of Participants Who Experience an Adverse Event (AE)
2. Number of Participants Who Discontinue Study Treatment Due to an AE

Secondary endpoints 13

1. Objective Response Rate (ORR) Per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) as Assessed by the Investigator
2. Duration of Response (DOR) Per RECIST 1.1 as Assessed by the Investigator
3. Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by the Investigator
4. Overall Survival (OS) Per RECIST 1.1 as Assessed by the Investigator
5. Area Under the Concentration-Time Curve (AUC) of MK-3120 Antibody-Drug Conjugate (ADC)
6. AUC of MK-3120 Total Antibody (TAb)
7. AUC of MK-3120 Free Payload
8. Maximum Concentration (Cmax) of MK-3120 ADC
9. Cmax of MK-3120 TAb
10. Cmax of MK-3120 Free Payload
11. Minimum concentration (Cmin) of MK-3120 ADC
12. Cmin of MK-3120 Tab
13. Cmin of MK-3120 Free Payload

Investigational products

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

Test 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

Konstantin Dobrenkov

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Konstantin Dobrenkov

Third parties 4

Locations

3 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 27 files

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

Application history

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