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Completed

NCT Number: NCT06242691

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

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Alfred Hospital ( Site 0103), Melbourne, Victoria, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-1200

Biological

IV Infusion

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

Primary outcomes

  1. Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1

    Time frame: 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

  2. Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2

    Time frame: 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.

  3. Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2

    Time frame: 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 outcomes

  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) - Part 2 Cohort A

    Time frame: Up to approximately 13 months

    ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by blinded independent central review (BICR). As pre-specified by the protocol, this analysis was to only include all participants randomized to Part 2 Cohort A who received at least 1 dose of study intervention.

  2. ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B

    Time frame: Up to approximately 13 months

    ORR was defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by the investigator.

  3. 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

    Time frame: Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    AUC0-336 was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine the AUC0-336 of the MK-1200-ADC.

  4. AUC0-336 of the Conjugated Toxin Payload (KL610023) - Parts 1 and 2

    Time frame: Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    AUC0-336 was defined as the area under the concentration versus time curve of KL610023 from time 0 to 336 Hours. Blood samples were collected at pre-specified timepoints to determine AUC0-336 of KL610023.

  5. Area Under the Concentration Versus Time Curve From Time 0 to the End of the Dosing Period (AUC0-tau) of MK-1200-ADC - Parts 1 and 2

    Time frame: Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    AUC0-tau was defined as the area under the concentration versus time curve of MK-1200-ADC from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of the MK-1200-ADC.

  6. AUC0-tau of KL610023 - Parts 1 and 2

    Time frame: Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    AUC0-tau is defined as the area under the concentration versus time curve of KL610023 from time 0 to the end of the 14-day dosing period (Cycle 4, 336 hours post-dose). Blood samples were collected at pre-specified timepoints to determine AUC0-tau of KL610023.

  7. Minimum Concentration (Cmin) of MK-1200-ADC - Part 1 & Part 2

    Time frame: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    Cmin was defined as the minimum concentration of MK-1200-ADC observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of the MK-1200-ADC.

  8. Cmin of KL610023 - Part 1 & Part 2

    Time frame: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    Cmin was defined as the minimum concentration of KL610023 observed in plasma after its administration and just prior to administration of a subsequent dose. Blood samples were collected at pre-specified timepoints to determine Cmin of KL610023.

  9. Maximum Concentration (Cmax) of MK-1200-ADC - Part 1 & Part 2

    Time frame: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    Cmax was defined as the maximum or 'peak' concentration of MK-1200-ADC observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of the MK-1200-ADC.

  10. Cmax of KL610023 - Part 1 & Part 2

    Time frame: Day 1 of Cycles 1 and 4: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.

    Cmax was defined as the maximum or 'peak' concentration of KL610023 observed after its administration. Blood samples were collected at pre-specified timepoints to determine Cmax of KL610023.

  11. Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A

    Time frame: Up to approximately 13 months

    For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from the first documented evidence of a CR or a PR until Progressive Disease (PD) or death due to any cause, whichever occurred first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, DOR for Part 2 Cohort A was planned to be assessed by BICR and was to include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention.

  12. DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B

    Time frame: Up to approximately 13 months

    For participants demonstrating a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from the first documented evidence of a CR or a PR until PD or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. The DOR as assessed by the investigator is reported.

  13. Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A

    Time frame: Up to approximately 13 months

    PFS was defined as the time from randomization to the first documented PD by BICR or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. As pre-specified by the protocol, PFS for Part 2 Cohort A was planned to be assessed by BICR and was to only include all participants randomized to Part 2 Cohort A who received at least one dose of study intervention.

  14. PFS Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B

    Time frame: Up to approximately 13 months

    PFS was defined as the time from randomization to the first documented PD by investigator or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of ≥5 mm. The appearance of one or more new lesions was also considered PD. PFS as assessed by the investigator is reported.

  15. Overall Survival (OS) - Part 1 & Part 2

    Time frame: Up to approximately 13 months

    OS was defined as the time from randomization to death due to any cause.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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