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

NCT06242691 | Completed Phase 1 FDA Drug

• 4 other identifiers: 1200-0022023-508684-68-00U1111-1298-7820MK-1200-002
• Study Type: interventional
• Target: 13
• Locations: 6 countries
• Sites: 16

Brief Summary

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Number of Participants who Experience One or More Dose-Limiting Toxicities (DLTs)

  The occurrence of any of the following toxicities within 28 days after the first dose of study intervention will be considered a DLT, if assessed by the investigator to be possibly, probably, or definitely related to study intervention administration: * Grade 4 nonhematologic toxicity (not laboratory). Any nonhematologic AE ≥Grade 3 in severity should be considered a DLT, with pre-specified exceptions * Any Grade 3 or Grade 4 laboratory value (hematologic or nonhematologic), with pre-specified exceptions * Febrile neutropenia Grade 3 or Grade 4 as prespecified by the protocol * Prolonged delay (\>2 weeks) in initiating Cycle 2 due to intervention-related toxicity * Any intervention-related toxicity that causes the participant to discontinue intervention during Cycle 1 * Missing \>25% of MK-1200 doses as a result of drug-related AEs during the first cycle * Grade 5 toxicity

  Up to approximately 28 days

• Number of Participants who Experience One or More Adverse Events (AEs)

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported for each arm.

  Up to approximately 16 months

• Number of Participants who Discontinue Study Intervention Due to an AE

  An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study intervention due to an AE will be reported for each arm.

  Up to approximately 15 months

Secondary Outcomes (10)

• 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)

  Up to approximately 16 months

• ORR per RECIST 1.1 as Assessed by Investigator

  Up to approximately 16 months

• Area under the curve (AUC) of MK-1200

  Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to 15 months): predose and 0.5 hours postdose. Cycle is 14 days.

• Minimum Concentration (Cmin) of MK-1200

  Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to 15 months): predose and 0.5 hours postdose. Cycle is 14 days.

• Maximum Concentration (Cmax) of MK-1200

  Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 48, 96, 168, and 240 hours postdose; Cycles 2-3 Days 1 and 8: predose and 0.5 hours postdose; Day 1 of Cycles 5 onward (up to 15 months): predose and 0.5 hours postdose. Cycle is 14 days.

Study Arms (3)

Part 1: MK-1200

EXPERIMENTAL

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.

Biological: MK-1200; Drug: Antiemetic

Part 2: MK-1200 Cohort A

EXPERIMENTAL

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.

Biological: MK-1200; Drug: Antiemetic

Part 2: MK-1200 Cohort B

EXPERIMENTAL

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

Biological: MK-1200; Drug: Antiemetic

Interventions

MK-1200 BIOLOGICAL

IV Infusion

Part 1: MK-1200; Part 2: MK-1200 Cohort A; Part 2: MK-1200 Cohort B

Antiemetic DRUG

One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion

Part 1: MK-1200; Part 2: MK-1200 Cohort A; Part 2: MK-1200 Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (16)

The University of Louisville, James Graham Brown Cancer Center ( Site 0004)

Louisville, Kentucky, 40202, United States

Location

START Midwest ( Site 0014)

Grand Rapids, Michigan, 49546, United States

Location

South Texas Accelerated Research Therapeutics (START) ( Site 0005)

San Antonio, Texas, 78229, United States

Location

START Mountain Region ( Site 0015)

West Valley City, Utah, 84119, United States

Location

University of Virginia Health System-Hematology-Oncology ( Site 0009)

Charlottesville, Virginia, 22908, United States

Location

The Alfred Hospital ( Site 0103)

Melbourne, Victoria, 3004, Australia

Location

Bradfordhill-Clinical Area ( Site 0301)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Beijing Cancer hospital-Digestive Oncology ( Site 0401)

Beijing, Beijing Municipality, 100142, China

Location

Fujian Cancer Hospital-oncology department ( Site 0409)

Fuzhou, Fujian, 350000, China

Location

First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)

Huai'an, Jiangsu, 223300, China

Location

Rambam Health Care Campus-Oncology Division ( Site 0602)

Haifa, 3109601, Israel

Location

Hadassah Medical Center ( Site 0604)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center-Oncology ( Site 0603)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center ( Site 0605)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center ( Site 0601)

Tel Aviv, 6423906, Israel

Location

Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)

Seoul, 06351, South Korea

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Interventions

Antiemetics

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Gastrointestinal Agents

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 5, 2024
• Study Start: February 28, 2024
• Primary Completion: June 17, 2025
• Study Completion: June 17, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

CL (1); AU (1); CN (3); US (5); IL (5); KR (1)