MK-1200 for Advanced Solid Tumors

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

completed 17 Jun 2025

Decision date (initial)

2024-06-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2023-508684-68-00

WHO UTN

U1111-1298-7820

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

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

To evaluate the safety and tolerability of MK-1200 monotherapy (Part 1 and Part 2)

Secondary objectives 5

1. To evaluate the antitumor activity of MK-1200 monotherapy during randomized dose evaluation at 2 different doses as measured by ORR per RECIST 1.1 as assessed by BICR (Part 2 Cohort A)
2. To evaluate the antitumor activity of MK-1200 monotherapy measured by ORR per RECIST 1.1 as assessed by the investigator (Part 1 and Part 2 Cohort B)
3. To evaluate the PK of MK-1200 monotherapy (Part 1 and Part 2)
4. To evaluate the antitumor activity of MK-1200 monotherapy as assessed by BICR (as appropriate) and measured by DOR, PFS, and OS (Part 2 Cohort A)
5. To evaluate the antitumor activity of MK-1200 monotherapy as assessed by the investigator (as appropriate) and measured by DOR, PFS, and OS (Part 1 and Part 2 Cohort B)

Conditions and MedDRA coding

Advanced solid tumor

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma
2. Participants who experienced Adverse Events (AEs) due to previous anticancer therapies must have recovered to < Grade 1 or baseline
3. Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
4. Received and progressed on or after 1 or 2 prior lines of therapy

Exclusion criteria 13

1. Active severe digestive disease
2. History of major cardiovascular diseases
3. History of acute myocardial infarction; unstable angina; stroke or transient ischemic attack within 6 months prior to the first dose of study intervention
4. Cardiac pacemaker use
5. Diabetes or hypertension that cannot be controlled by medication
6. HIV-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
7. Received prior systemic anticancer therapy including investigational agents within 4 weeks before study intervention
8. Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids
9. Known additional malignancy that is progressing or has required active treatment within the past 2 years
10. Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
11. Active infection requiring systemic therapy
12. History of known Hepatitis B or known active Hepatitis C viral infection
13. Have not adequately recovered from major surgery or have ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Number of participants who experience one or more dose-limiting toxicities (DLTs)
2. Number of participants who experience one or more adverse events (AEs)
3. Number of participants who discontinue study intervention due to an AE

Secondary endpoints 10

1. Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR)
2. ORR per RECIST 1.1 as assessed by investigator
3. Area under the curve (AUC) of MK-1200
4. Minimum concentration (Cmin) of MK-1200
5. Maximum concentration (Cmax) of MK-1200
6. Duration of response (DOR) per RECIST 1.1 as assessed by BICR
7. DOR per RECIST 1.1 as assessed by investigator
8. Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
9. PFS per RECIST 1.1 as assessed by investigator
10. Overall Survival (OS)

Investigational products

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

Test 1

Auxiliary 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Erik Knelson

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Erik Knelson

Third parties 5

Locations

4 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Corrective measures 1 · Art. 77 CTR

Results and documents

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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 6 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