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Sikkerhet og effekt av MK-1200 hos deltakere med avanserte solide svulster

11. mai 2026 oppdatert av: Merck Sharp & Dohme LLC

En fase 1/2 åpen studie for å evaluere sikkerheten og effektiviteten til MK-1200 hos deltakere med avanserte solide svulster

Hensikten med denne studien er å vurdere effektiviteten og sikkerheten til MK-1200 monoterapi hos deltakere med avansert/metastatisk gastrisk/gastroøsofageal junction (GEJ) kreft, spiserørskreft, galleveiskreft og bukspyttkjertel ductalt adenokarsinom som har fått eller vært intolerante til alle behandlinger som er kjent for å gi klinisk fordel. Del 1 av studien vil være en doseeskalering for å bestemme maksimal tolerert dose (MTD). Del 2 vil evaluere sikkerhet og effekt av MK-1200 ved 2 forskjellige doser

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

13

Fase

  • Fase 2
  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital ( Site 0103)
  • Chile
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill-Clinical Area ( Site 0301)
  • Forente stater
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40202
        • The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49546
        • START Midwest ( Site 0014)
    • Texas
      • San Antonio, Texas, Forente stater, 78229
        • South Texas Accelerated Research Therapeutics (START) ( Site 0005)
    • Utah
      • West Valley City, Utah, Forente stater, 84119
        • START Mountain Region ( Site 0015)
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22908
        • University of Virginia Health System-Hematology-Oncology ( Site 0009)
  • Israel
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Oncology Division ( Site 0602)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center ( Site 0604)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center-Oncology ( Site 0603)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center ( Site 0605)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center ( Site 0601)
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Beijing Cancer hospital-Digestive Oncology ( Site 0401)
    • Fujian
      • Fuzhou, Fujian, Kina, 350000
        • Fujian Cancer Hospital-oncology department ( Site 0409)
    • Jiangsu
      • Huai'an, Jiangsu, Kina, 223300
        • First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)
  • Sør -Korea
      • Seoul, Sør -Korea, 06351
        • Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Bekreftet avansert (ikke-opererbar og/eller metastatisk) solid svulst: magekreft (inkludert gastroøsofageal junction cancer), esophageal cancer, galleveiskreft eller pankreas duktal adenokarsinom
  • Deltakere som har opplevd uønskede hendelser (AE) på grunn av tidligere kreftbehandlinger må ha kommet seg til < grad 1 eller baseline
  • Humant immunsviktvirus (HIV)-infiserte deltakere må ha godt kontrollert HIV på antiretroviral terapi
  • Hepatitt B-overflateantigen (HBsAg)-positive deltakere er kvalifisert hvis de har mottatt hepatitt B-virus (HBV) antiviral behandling i minst 4 uker og har uoppdagelig HBV-virusmengde
  • Deltakere med en historie med hepatitt C-virus (HCV)-infeksjon er kvalifisert hvis HCV-virusmengden ikke kan påvises
  • Mottatt og utviklet seg på eller etter 1 eller 2 tidligere behandlingslinjer

Ekskluderingskriterier:

  • Aktiv alvorlig fordøyelsessykdom
  • Historie om store hjerte- og karsykdommer
  • Anamnese med akutt hjerteinfarkt; ustabil angina; slag eller forbigående iskemisk anfall innen 6 måneder før første dose av studieintervensjon
  • Bruk av pacemaker
  • Diabetes eller hypertensjon som ikke kan kontrolleres med medisiner
  • HIV-infiserte deltakere med en historie med Kaposis sarkom og/eller multisentrisk Castlemans sykdom
  • Fikk tidligere systemisk antikreftbehandling inkludert undersøkelsesmidler innen 4 uker før studieintervensjon
  • Fikk tidligere strålebehandling innen 2 uker etter start av studieintervensjon, eller har strålingsrelaterte toksisiteter som krever kortikosteroider
  • Kjent ytterligere malignitet som utvikler seg eller har krevd aktiv behandling i løpet av de siste 2 årene
  • Kjente aktive sentralnervesystem (CNS) metastaser og/eller karsinomatøs meningitt
  • Aktiv infeksjon som krever systemisk terapi
  • Har ikke restituert tilstrekkelig etter større operasjoner eller har pågående kirurgiske komplikasjoner

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Del 1: MK-1200
I del 1 vil deltakerne motta eskalerende doser av MK-1200 via intravenøs (IV) infusjon hver 2. uke (Q2W) inntil eventuelle seponeringskriterier er oppfylt.
Biologisk: MK-1200
IV infusjon
Legemiddel: Antiemetisk
Ett eller flere profylaktiske antiemetika (f.eks. 5-HT3-reseptorantagonister, deksametason, neurokinin-1-reseptorantagonister, etc.) kan velges basert på tidligere respons fra deltakerne på antiemetiske medisiner og individuelle faktorer, og vil bli administrert i henhold til godkjent produktetikett før MK-1200 infusjon
Eksperimentell: Part 2: MK-1200 Cohort A
In 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.
Biologisk: MK-1200
IV infusjon
Legemiddel: Antiemetisk
Ett eller flere profylaktiske antiemetika (f.eks. 5-HT3-reseptorantagonister, deksametason, neurokinin-1-reseptorantagonister, etc.) kan velges basert på tidligere respons fra deltakerne på antiemetiske medisiner og individuelle faktorer, og vil bli administrert i henhold til godkjent produktetikett før MK-1200 infusjon
Eksperimentell: Part 2: MK-1200 Cohort B
In 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.
Biologisk: MK-1200
IV infusjon
Legemiddel: Antiemetisk
Ett eller flere profylaktiske antiemetika (f.eks. 5-HT3-reseptorantagonister, deksametason, neurokinin-1-reseptorantagonister, etc.) kan velges basert på tidligere respons fra deltakerne på antiemetiske medisiner og individuelle faktorer, og vil bli administrert i henhold til godkjent produktetikett før MK-1200 infusjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1
Tidsramme: 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
During the first two 14-day cycles (Up to approximately 28 days)
Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2
Tidsramme: 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.
Up to approximately 12 months
Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2
Tidsramme: 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.
Up to approximately 9 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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
Tidsramme: 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.
Up to approximately 13 months
ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Tidsramme: 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.
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
Tidsramme: 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.
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 of the Conjugated Toxin Payload (KL610023) - Parts 1 and 2
Tidsramme: 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.
Cycle 1 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
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
Tidsramme: 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.
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 of KL610023 - Parts 1 and 2
Tidsramme: 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.
Cycle 4 Day 1: predose and 0.5, 2, 4, 8, 24, 72, 168, 240, and 336 hours postdose. A cycle was 14 days.
Minimum Concentration (Cmin) of MK-1200-ADC - Part 1 & Part 2
Tidsramme: 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.
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 of KL610023 - Part 1 & Part 2
Tidsramme: 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.
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.
Maximum Concentration (Cmax) of MK-1200-ADC - Part 1 & Part 2
Tidsramme: 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.
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 of KL610023 - Part 1 & Part 2
Tidsramme: 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.
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.
Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
Tidsramme: 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.
Up to approximately 13 months
DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Tidsramme: 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.
Up to approximately 13 months
Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
Tidsramme: 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.
Up to approximately 13 months
PFS Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Tidsramme: 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.
Up to approximately 13 months
Overall Survival (OS) - Part 1 & Part 2
Tidsramme: Up to approximately 13 months
OS was defined as the time from randomization to death due to any cause.
Up to approximately 13 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Merck Sharp & Dohme LLC

Etterforskere

  • Studieleder: Medical Director, Merck Sharp & Dohme LLC

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

28. februar 2024

Primær fullføring (Faktiske)

17. juni 2025

Studiet fullført (Faktiske)

17. juni 2025

Datoer for studieregistrering

Først innsendt

26. januar 2024

Først innsendt som oppfylte QC-kriteriene

26. januar 2024

Først lagt ut (Faktiske)

5. februar 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

11. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1200-002
  • U1111-1298-7820 (Registeridentifikator: UTN)
  • MK-1200-002 (Annen identifikator: MSD)
  • 2023-508684-68-00 (Registeridentifikator: EU CT)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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