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En klinisk studie av MK-2870 ensam eller med kemoterapi för att behandla gastrointestinala cancer (MK-9999-02A)

28 oktober 2026 uppdaterad av: Merck Sharp & Dohme LLC

En fas 1/2-studie för att utvärdera säkerheten och effekten av MK-2870 monoterapi eller i kombination med andra anticancermedel vid mag-tarmcancer

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn:

  • About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it
  • How many people have the cancer respond (get smaller or go away) to treatment

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

220

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.

Studiekontakt

Studieorter

  • Australien
    • New South Wales
      • Westmead, New South Wales, Australien, 2145
        • Aktiv, inte rekryterande
        • Westmead Hospital ( Site 0003)
    • Queensland
      • Brisbane, Queensland, Australien, 4029
        • Aktiv, inte rekryterande
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
    • Victoria
      • East Melbourne, Victoria, Australien, 3002
        • Aktiv, inte rekryterande
        • Epworth Freemasons ( Site 0005)
      • Frankston, Victoria, Australien, 3199
        • Aktiv, inte rekryterande
        • Frankston Hospital-Oncology and Haematology ( Site 0004)
    • Western Australia
      • Nedlands, Western Australia, Australien, 6009
        • Aktiv, inte rekryterande
        • One Clinical Research ( Site 0002)
  • Chile
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Rekrytering
        • James Lind Centro de Investigacion del Cancer ( Site 0048)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +56452982404
    • Region M. de Santiago
      • Providencia, Region M. de Santiago, Chile, 7500921
        • Aktiv, inte rekryterande
        • FALP-UIDO ( Site 0041)
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Rekrytering
        • Clínica UC San Carlos de Apoquindo ( Site 0043)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +56227548924
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Aktiv, inte rekryterande
        • Bradfordhill-Clinical Area ( Site 0047)
  • Förenta staterna
    • California
      • Los Angeles, California, Förenta staterna, 90095
        • Rekrytering
        • UCLA ( Site 0317)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 310-633-8400
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • Rekrytering
        • University of Colorado Anschutz Medical Campus ( Site 0299)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 303-724-8644
      • Aurora, Colorado, Förenta staterna, 80045
        • Rekrytering
        • University of Colorado Anschutz Medical Campus ( Site 0325)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 720-848-0300
      • Aurora, Colorado, Förenta staterna, 80045
        • Rekrytering
        • University of Colorado Anschutz Medical Campus ( Site 0326)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 720-848-0300
    • District of Columbia
      • Washington D.C., District of Columbia, Förenta staterna, 20016
        • Aktiv, inte rekryterande
        • Sibley Memorial Hospital ( Site 0310)
    • Florida
      • Gainesville, Florida, Förenta staterna, 32610
        • Rekrytering
        • University of Florida College of Medicine ( Site 0281)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 352-265-5121
      • Miami Beach, Florida, Förenta staterna, 33140
        • Avslutad
        • Mount Sinai Cancer Center ( Site 0287)
    • Georgia
      • Marietta, Georgia, Förenta staterna, 30060
        • Avslutad
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
    • New York
      • Mineola, New York, Förenta staterna, 11501
        • Rekrytering
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 646-599-4083
      • New York, New York, Förenta staterna, 10016
        • Rekrytering
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 212-731-6000
    • Texas
      • Houston, Texas, Förenta staterna, 77030
        • Rekrytering
        • University of Texas MD Anderson Cancer Center ( Site 0316)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 713-792-2828
    • Virginia
      • Roanoke, Virginia, Förenta staterna, 24014
        • Rekrytering
        • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 540-491-2240
    • Wisconsin
      • Madison, Wisconsin, Förenta staterna, 53792
        • Rekrytering
        • University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 800-622-8922
  • Italien
      • Roma, Italien, 00168
        • Rekrytering
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 390458128116
    • Lombardy
      • Milan, Lombardy, Italien, 20133
        • Rekrytering
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 390223903807
      • Milan, Lombardy, Italien, 20162
        • Rekrytering
        • ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 390264442291
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Rekrytering
        • National Cancer Center Hospital East ( Site 0121)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +81-4-7133-1111
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Rekrytering
        • Kanagawa Cancer Center ( Site 0122)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +81-45-520-2222
  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1H 8L6
        • Rekrytering
        • The Ottawa Hospital Cancer Centre ( Site 0027)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 613-737-7700 x70185
    • Quebec
      • Montreal, Quebec, Kanada, H2X 0A9
        • Rekrytering
        • Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 5148908000
      • Montreal, Quebec, Kanada, H4A 3J1
        • Aktiv, inte rekryterande
        • McGill University Health Centre ( Site 0023)
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100142
        • Aktiv, inte rekryterande
        • Beijing Cancer hospital-Digestive Oncology ( Site 0061)
    • Fujian
      • Fuzhou, Fujian, Kina, 350025
        • Rekrytering
        • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 0591-22859663
    • Hubei
      • Wuhan, Hubei, Kina, 430024
        • Aktiv, inte rekryterande
        • Wuhan Union Hospital Cancer Center. ( Site 0064)
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Aktiv, inte rekryterande
        • Hunan Cancer Hospital-intervention department ( Site 0066)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200127
        • Aktiv, inte rekryterande
        • Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • Rekrytering
        • West China Hospital, Sichuan University ( Site 0068)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 028-85423203
  • Schweiz
    • Canton Ticino
      • Bellinzona, Canton Ticino, Schweiz, 6500
        • Rekrytering
        • Ospedale Regionale Bellinzona e Valli ( Site 0201)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +41918119039
    • Canton of Geneva
      • Geneva, Canton of Geneva, Schweiz, 1211
        • Rekrytering
        • Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +41223729862
  • Spanien
      • Barcelona, Spanien, 08035
        • Aktiv, inte rekryterande
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanien, 28009
        • Rekrytering
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 914269070
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spanien, 33011
        • Aktiv, inte rekryterande
        • Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
  • Storbritannien
      • Coventry, Storbritannien, CV2 2DX
        • Rekrytering
        • University Hospital Coventry & Warwickshire ( Site 0266)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 02476967485
    • England
      • London, England, Storbritannien, E1 1RD
        • Rekrytering
        • Barts Health NHS Trust ( Site 0263)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 07918804584
      • London, England, Storbritannien, NW3 2QG
        • Rekrytering
        • Royal Free Hospital ( Site 0262)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 02077940500 ext38682
  • Sydkorea
      • Seoul, Sydkorea, 03080
        • Rekrytering
        • Seoul National University Hospital ( Site 0161)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: 82-2-2072-0701
      • Seoul, Sydkorea, 05505
        • Rekrytering
        • Asan Medical Center ( Site 0163)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +82 2 3010 3945
      • Seoul, Sydkorea, 06351
        • Rekrytering
        • Samsung Medical Center ( Site 0162)
        • Kontakt:
          • Study Coordinator
          • Telefonnummer: +82234103549
      • Seoul, Sydkorea, 03722
        • Aktiv, inte rekryterande
        • Severance Hospital, Yonsei University Health System ( Site 0164)
  • Taiwan
      • Taichung, Taiwan, 404332
        • Aktiv, inte rekryterande
        • China Medical University Hospital ( Site 0223)
      • Tainan, Taiwan, 704
        • Aktiv, inte rekryterande
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
      • Taipei, Taiwan, 10002
        • Aktiv, inte rekryterande
        • National Taiwan University Hospital-Oncology ( Site 0225)
      • Taipei, Taiwan, 112
        • Aktiv, inte rekryterande
        • Taipei Veterans General Hospital ( Site 0221)
      • Taoyuan, Taiwan, 33305
        • Aktiv, inte rekryterande
        • Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
  • Turkiet (Türkiye)
      • Ankara, Turkiet (Türkiye), 06800
        • Avslutad
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
      • Ankara, Turkiet (Türkiye), 06230
        • Avslutad
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has one of the following cancers:

    • Unresectable or metastatic colorectal cancer and has received prior therapy for the cancer
    • Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer
    • Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer
    • Advanced and/or unresectable BTC and has not received prior therapy for the cancer

  • For participants who have received prior therapy for cancer: Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of severe eye disease
  • For participants who have received prior therapy for cancer: Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
  • History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening

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: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Sacituzumab tirumotecan + Chemotherapy

Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Biologisk: Sacituzumab tirumotecan

Given by IV infusion.

Andra namn:
  • SKB264
  • MK-2870
Läkemedel: Fluorouracil (5-FU)

5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.

Läkemedel: Leucovorin (LV) or levoleucovorin

LV or levoleucovorin is administered by IV infusion every 2 weeks.

Läkemedel: Rescue medication

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

Läkemedel: Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
Experimentell: Sacituzumab tirumotecan

Participants will receive sacituzumab tirumotecan in one of two dose levels every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Biologisk: Sacituzumab tirumotecan

Given by IV infusion.

Andra namn:
  • SKB264
  • MK-2870
Läkemedel: Rescue medication

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

Läkemedel: Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
Experimentell: Sacituzumab tirumotecan + Cisplatin + Pembrolizumab

Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.
Biologisk: Sacituzumab tirumotecan

Given by IV infusion.

Andra namn:
  • SKB264
  • MK-2870
Läkemedel: Rescue medication

Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.

Läkemedel: Supportive care measures

Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.

Läkemedel: Cisplatin

Given by IV infusion.

Andra namn:
  • PLATINOL®
Biologisk: Pembrolizumab

Given by IV infusion.

Andra namn:
  • MK-3475
  • KEYTRUDA®

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Tidsram: Up to approximately 4 weeks

A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
Up to approximately 4 weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
Tidsram: Up to approximately 63 months

An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
Up to approximately 63 months
Number of Participants who Discontinue Study Treatment due to an AE
Tidsram: Up to approximately 63 months

An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
Up to approximately 63 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Tidsram: Up to approximately 63 months

ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to approximately 63 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Tidsram: Up to approximately 63 months

For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 63 months
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Tidsram: Up to approximately 63 months

PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to 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. PFS as assessed by BICR will be presented.
Up to approximately 63 months
Overall Survival (OS)
Tidsram: Up to approximately 63 months

OS is the length of time from when the participant starts treatment until death from any cause
Up to approximately 63 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck Sharp & Dohme LLC

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)

20 juni 2024

Primärt slutförande (Beräknad)

16 oktober 2029

Avslutad studie (Beräknad)

16 oktober 2029

Studieregistreringsdatum

Först inskickad

20 maj 2024

Först inskickad som uppfyllde QC-kriterierna

20 maj 2024

Första postat (Faktisk)

24 maj 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

29 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 9999-02A
  • MK-9999-02A (Annan identifierare: MSD)
  • U1111-1298-8273 (Registeridentifierare: UTN)
  • jRCT2031240178 (Registeridentifierare: jRCT)
  • 2023-508703-21-00 (Registeridentifierare: EU CT)
  • 2023 (U.S.S. NIH-anslag/kontrakt)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

https://trialstransparency.msdclinicaltrials.com/pdf/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 .

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