Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: Antiemetic

Biological: MK-1200

Study type

Interventional

Funder types

Industry

Identifiers

NCT06242691

MK-1200-002 (Other Identifier)

2023-508684-68-00 (Registry Identifier)

1200-002

U1111-1298-7820 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal junction (GEJ) cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma who have received, or been intolerant to, all treatments known to confer clinical benefit. Part 1 of the study will be a dose escalation to determine the maximum tolerated dose (MTD). Part 2 will evaluate safety and efficacy of MK-1200 at 2 different doses

Enrollment

304 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Confirmed advanced (unresectable and/or metastatic) solid tumor: gastric cancer (including gastroesophageal junction cancer), esophageal cancer, biliary tract cancer, or pancreatic ductal adenocarcinoma
Participants who experienced Adverse Events (AEs) due to previous anticancer therapies must have recovered to < Grade 1 or baseline
Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy
Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load
Participants with a history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable
Received and progressed on or after 1 or 2 prior lines of therapy

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

304 participants in 3 patient groups

Part 1: MK-1200

Experimental group

Description:

In Part 1, participants will receive escalating doses of MK-1200 via intravenous (IV) infusion every 2 weeks (Q2W) until any discontinuation criteria are met.

Treatment:

Biological: MK-1200

Drug: Antiemetic

Part 2: MK-1200 Cohort A

Experimental group

Description:

In Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 via IV infusion Q2W until any discontinuation criteria are met.

Treatment:

Biological: MK-1200

Drug: Antiemetic

Part 2: MK-1200 Cohort B

Experimental group