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MK-1200

Phase 1

Advanced Solid Tumors | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jun 5, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment13

FDA Designations

No designations recorded

Clinical trial landscape

MK-1200 · 1 trial · 1 indication

Phase 1 1
NCT06242691Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)Advanced Solid Tumors
COMPLETED13 Analytics
PHASE1COMPLETED
Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)
Advanced Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1
During the first two 14-day cycles (Up to approximately 28 days)

The occurrence of any of the following toxicities within 28 days after the first dose of study intervention were 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 was 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 caused the participant to discontinue intervention during Cycle 1 * Missed \>25% of MK-1200 doses as a result of drug-related AEs during the first cycle * Grade 5 toxicity

Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2
Up to approximately 12 months

An AE was 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 experienced an AE is reported for each arm.

Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2
Up to approximately 9 months

An AE was 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 discontinued study intervention due to an AE is reported for each arm.

Secondary Endpoints

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) - Part 2 Cohort A
Up to approximately 13 months
ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Up to approximately 13 months
Area Under the Concentration Versus Time Curve From Time 0 to 336 Hours (AUC0-336) of MK-1200-Antibody-Drug Conjugate (ADC) - Parts 1 and 2
Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: MK-1200EXPERIMENTALIn Part 1, participants will receive escalating doses of MK-1200 via intravenous (IV) infusion every 2 weeks (Q2W) until any discontinuation criteria are met.
Part 2: MK-1200 Cohort AEXPERIMENTALIn Part 2, participants in Cohort A will receive either Dose 1 or Dose 2 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met.
Part 2: MK-1200 Cohort BEXPERIMENTALIn Part 2, participants in Cohort B will receive Dose 1 of MK-1200 (determined from Part 1) via IV infusion Q2W until any discontinuation criteria are met.

Interventions

NameTypeDescription
MK-1200BIOLOGICALIV Infusion
AntiemeticDRUGOne 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
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites16

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 antica...

Countries:United StatesAustraliaChileChinaIsraelSouth Korea
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumors")

Recent Changes (Last 90 Days)

MEDIUMJul 6, 2026NCT06242691TRIAL_REMOVED: changed
MEDIUMJul 6, 2026NCT06242691TRIAL_REMOVED: changed
MEDIUMJul 6, 2026NCT06242691TRIAL_REMOVED: changed

Frequently asked questions about MK-1200

What is MK-1200 used for?

MK-1200 is an investigational monoclonal antibody being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The drug is being studied in patients with advanced solid tumors who are at least 18 years old.

Who makes MK-1200?

MK-1200 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody in patients with advanced solid tumors.

What phase is MK-1200 in?

MK-1200 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The drug is being studied in a completed Phase 1 trial that enrolled 13 participants with advanced solid tumors.

What clinical trials is MK-1200 in?

MK-1200 has one completed clinical trial, identified as NCT06242691, titled "Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)." This Phase 1 trial enrolled 13 participants and was conducted in the United States, Australia, Chile, China, Israel, and South Korea.

Is MK-1200 a monoclonal antibody?

Yes, MK-1200 is a monoclonal antibody, a type of biologic drug designed to target specific proteins involved in disease. It is being investigated as a potential treatment for advanced solid tumors. The drug is currently in Phase 1 clinical trials and is not yet approved for commercial use.