Säkerhet och effektivitet hos MK-1200 hos deltagare med avancerade solida tumörer
11 maj 2026 uppdaterad av: Merck Sharp & Dohme LLC
En fas 1/2 öppen studie för att utvärdera säkerheten och effekten av MK-1200 hos deltagare med avancerade solida tumörer
Syftet med denna studie är att bedöma effektiviteten och säkerheten av MK-1200 monoterapi hos deltagare med avancerad/metastaserad gastrisk/gastroesofageal junction (GEJ) cancer, matstrupscancer, gallvägscancer och pankreatisk duktal adenokarcinom som har fått eller varit intoleranta till alla behandlingar som är kända för att ge klinisk nytta.
Del 1 av studien kommer att vara en dosökning för att bestämma den maximala tolererade dosen (MTD).
Del 2 kommer att utvärdera säkerhet och effekt av MK-1200 vid 2 olika doser
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
13
Fas
- Fas 2
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Victoria
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Melbourne, Victoria, Australien, 3004
- The Alfred Hospital ( Site 0103)
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Region M. de Santiago
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Santiago, Region M. de Santiago, Chile, 8420383
- Bradfordhill-Clinical Area ( Site 0301)
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40202
- The University of Louisville, James Graham Brown Cancer Center ( Site 0004)
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Michigan
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Grand Rapids, Michigan, Förenta staterna, 49546
- START Midwest ( Site 0014)
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Texas
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San Antonio, Texas, Förenta staterna, 78229
- South Texas Accelerated Research Therapeutics (START) ( Site 0005)
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Utah
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West Valley City, Utah, Förenta staterna, 84119
- START Mountain Region ( Site 0015)
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Virginia
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Charlottesville, Virginia, Förenta staterna, 22908
- University of Virginia Health System-Hematology-Oncology ( Site 0009)
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Haifa, Israel, 3109601
- Rambam Health Care Campus-Oncology Division ( Site 0602)
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Jerusalem, Israel, 9112001
- Hadassah Medical Center ( Site 0604)
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Petah Tikva, Israel, 4941492
- Rabin Medical Center-Oncology ( Site 0603)
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Ramat Gan, Israel, 5265601
- Sheba Medical Center ( Site 0605)
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center ( Site 0601)
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100142
- Beijing Cancer hospital-Digestive Oncology ( Site 0401)
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Fujian
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Fuzhou, Fujian, Kina, 350000
- Fujian Cancer Hospital-oncology department ( Site 0409)
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Jiangsu
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Huai'an, Jiangsu, Kina, 223300
- First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 0415)
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Seoul, Sydkorea, 06351
- Samsung Medical Center-Division of Hematology/Oncology ( Site 1003)
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
- Bekräftad avancerad (icke-opererbar och/eller metastaserad) solid tumör: magcancer (inklusive cancer i gastroesofageal junction), matstrupscancer, gallvägscancer eller pankreatisk ductal adenocarcinom
- Deltagare som upplevt biverkningar på grund av tidigare anticancerterapier måste ha återhämtat sig till < grad 1 eller baslinje
- Humant immunbristvirus (HIV)-infekterade deltagare måste ha välkontrollerad HIV på antiretroviral terapi
- Hepatit B-ytantigen (HBsAg) positiva deltagare är berättigade om de har fått hepatit B-virus (HBV) antiviral behandling i minst 4 veckor och har odetekterbar HBV-virusmängd
- Deltagare med en historia av hepatit C-virus (HCV)-infektion är berättigade om HCV-virusmängd inte kan upptäckas
- Mottogs och utvecklades på eller efter 1 eller 2 tidigare behandlingsrader
Exklusions kriterier:
- Aktiv allvarlig matsmältningssjukdom
- Historik om stora hjärt-kärlsjukdomar
- Historik av akut hjärtinfarkt; instabil angina; stroke eller övergående ischemisk attack inom 6 månader före den första dosen av studieintervention
- Användning av pacemaker
- Diabetes eller högt blodtryck som inte kan kontrolleras med medicin
- HIV-infekterade deltagare med en historia av Kaposis sarkom och/eller multicentrisk Castlemans sjukdom
- Fick tidigare systemisk anticancerbehandling inklusive prövningsmedel inom 4 veckor före studieintervention
- Fick tidigare strålbehandling inom 2 veckor efter start av studieintervention, eller har strålningsrelaterade toxiciteter som kräver kortikosteroider
- Känd ytterligare malignitet som fortskrider eller har krävt aktiv behandling under de senaste 2 åren
- Kända metastaser från det aktiva centrala nervsystemet (CNS) och/eller karcinomatös meningit
- Aktiv infektion som kräver systemisk terapi
- Har inte återhämtat sig tillräckligt efter en större operation eller har pågående kirurgiska komplikationer
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Del 1: MK-1200
I del 1 kommer deltagarna att få eskalerande doser av MK-1200 via intravenös (IV) infusion varannan vecka (Q2W) tills eventuella avbrottskriterier är uppfyllda.
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IV infusion
Ett eller flera profylaktiska antiemetika (t.ex.
5-HT3-receptorantagonister, dexametason, neurokinin-1-receptorantagonister, etc.) kan väljas baserat på tidigare svar från deltagarna på antiemetiska läkemedel och individuella faktorer, och kommer att administreras enligt godkänd produktetikett före MK-1200-infusion
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Experimentell: 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.
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IV infusion
Ett eller flera profylaktiska antiemetika (t.ex.
5-HT3-receptorantagonister, dexametason, neurokinin-1-receptorantagonister, etc.) kan väljas baserat på tidigare svar från deltagarna på antiemetiska läkemedel och individuella faktorer, och kommer att administreras enligt godkänd produktetikett före MK-1200-infusion
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Experimentell: 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.
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IV infusion
Ett eller flera profylaktiska antiemetika (t.ex.
5-HT3-receptorantagonister, dexametason, neurokinin-1-receptorantagonister, etc.) kan väljas baserat på tidigare svar från deltagarna på antiemetiska läkemedel och individuella faktorer, och kommer att administreras enligt godkänd produktetikett före MK-1200-infusion
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) - Part 1
Tidsram: During the first two 14-day cycles (Up to approximately 28 days)
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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:
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During the first two 14-day cycles (Up to approximately 28 days)
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Number of Participants Who Experience One or More Adverse Events (AEs) - Part 1 & Part 2
Tidsram: Up to approximately 12 months
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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.
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Up to approximately 12 months
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Number of Participants Who Discontinue Study Intervention Due to an AE - Part 1 & Part 2
Tidsram: Up to approximately 9 months
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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.
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Up to approximately 9 months
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: Up to approximately 13 months
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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.
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Up to approximately 13 months
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ORR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Tidsram: Up to approximately 13 months
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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.
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Up to approximately 13 months
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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
Tidsram: 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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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.
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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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AUC0-336 of the Conjugated Toxin Payload (KL610023) - Parts 1 and 2
Tidsram: 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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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.
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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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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
Tidsram: 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.
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Cycle 4 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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AUC0-tau of KL610023 - Parts 1 and 2
Tidsram: 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.
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Cycle 4 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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Minimum Concentration (Cmin) of MK-1200-ADC - Part 1 & Part 2
Tidsram: 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.
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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.
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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.
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Cmin of KL610023 - Part 1 & Part 2
Tidsram: 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.
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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.
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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.
|
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Maximum Concentration (Cmax) of MK-1200-ADC - Part 1 & Part 2
Tidsram: 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.
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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.
|
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Cmax of KL610023 - Part 1 & Part 2
Tidsram: 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.
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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.
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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.
|
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Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
Tidsram: Up to approximately 13 months
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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.
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Up to approximately 13 months
|
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DOR Per RECIST 1.1 as Assessed by Investigator - Part 1 & Part 2 Cohort B
Tidsram: 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
|
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Progression-Free Survival (PFS) Per RECIST 1.1 as Assessed by BICR - Part 2 Cohort A
Tidsram: 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
Tidsram: 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
Tidsram: Up to approximately 13 months
|
OS was defined as the time from randomization to death due to any cause.
|
Up to approximately 13 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Medical Director, Merck Sharp & Dohme LLC
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 februari 2024
Primärt slutförande (Faktisk)
17 juni 2025
Avslutad studie (Faktisk)
17 juni 2025
Studieregistreringsdatum
Först inskickad
26 januari 2024
Först inskickad som uppfyllde QC-kriterierna
26 januari 2024
Första postat (Faktisk)
5 februari 2024
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1200-002
- U1111-1298-7820 (Registeridentifierare: UTN)
- MK-1200-002 (Annan identifierare: MSD)
- 2023-508684-68-00 (Registeridentifierare: EU CT)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .