En undersøgelse for at vurdere uønskede hændelser og hvordan intravenøst (IV) infunderet ABBV-400 bevæger sig gennem kroppen som monoterapi sammenlignet med trifluridin og tipiracil (LONSURF) orale tabletter plus IV infunderet Bevacizumab hos voksne deltagere med c-Met overudtrykt refraktær metastatisk farve Kræft (AndroMETa-CRC-)
26. maj 2026 opdateret af: AbbVie
Et åbent, randomiseret, kontrolleret, globalt fase 3-studie, der sammenligner ABBV-400 monoterapi med LONSURF (trifluridin og tipiracil) plus bevacizumab hos personer med c-Met overudtrykt refraktær metastatisk kolorektal cancer
Kolorektal cancer (CRC) er den tredjehyppigste kræfttype, der diagnosticeres på verdensplan og i Kina. Formålet med denne undersøgelse er at vurdere bivirkninger og hvordan ABBV-400 bevæger sig gennem kroppen som monoterapi sammenlignet med trifluridin og tipiracil (LONSURF) plus bevacizumab hos voksne deltagere med c-Met overudtrykt refraktær metastatisk kolorektal cancer (mCRC).
ABBV-400 er et forsøgslægemiddel, der udvikles til behandling af CRC. Deltagerne sættes i behandlingsarme som en del af 2 faser. Hver behandlingsarm i trin 1 modtager en forskellig dosis af ABBV-400. Hver behandlingsarm i trin 2 modtager den optimale dosis af ABBV-400 eller LONSURF plus bevacizumab. Op til cirka 460 voksne deltagere med c-Met overudtrykt (OE) refraktær mCRC vil blive tilmeldt undersøgelsen på cirka 160 steder i 15-20 lande.
I trin 1 vil deltagerne modtage intravenøst (IV) infunderet ABBV-400 dosis A eller B. I trin 2 vil deltagerne modtage den optimale dosis af IV infunderet ABBV-400 eller standardbehandlingen (SOC), LONSURF orale tabletter plus IV infunderet bevacizumab. Den samlede studietid vil være cirka 4 år.
Der kan være højere behandlingsbyrde for deltagere i dette forsøg sammenlignet med deres standardbehandling. Deltagerne vil deltage i regelmæssige besøg under undersøgelsen på en godkendt institution (hospital eller klinik). Effekten af behandlingen vil hyppigt blive kontrolleret ved lægelige vurderinger, blodprøver, spørgeskemaer og bivirkninger.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
74
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Queensland
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South Brisbane, Queensland, Australien, 4101
- Mater Hospital Brisbane /ID# 268360
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California
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Duarte, California, Forenede Stater, 91010
- City of Hope National Medical Center /ID# 267875
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Irvine, California, Forenede Stater, 92618
- City of Hope - Orange County Lennar Foundation Cancer Center /ID# 270655
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Los Angeles, California, Forenede Stater, 90033
- USC Norris Comprehensive Cancer Center /ID# 268131
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Colorado
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Golden, Colorado, Forenede Stater, 80401
- Lutheran Medical Center- Cancer Centers of Colorado /ID# 268175
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Connecticut
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New Haven, Connecticut, Forenede Stater, 06510
- Yale University School of Medicine /ID# 269125
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Florida
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Orlando, Florida, Forenede Stater, 32803
- AdventHealth Orlando /ID# 267970
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Winship Cancer Institute of Emory University /ID# 266884
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Idaho
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Boise, Idaho, Forenede Stater, 83712
- St. Luke's Cancer Institute: Boise /ID# 268095
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern Medicine - Northwestern Memorial Hospital /ID# 268610
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Hinsdale, Illinois, Forenede Stater, 60521
- Hope And Healing Cancer Services /ID# 268541
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Springfield, Illinois, Forenede Stater, 62702
- Springfield Clinic - First /ID# 268666
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46250
- Community Cancer Center North /ID# 267965
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Mississippi
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Hattiesburg, Mississippi, Forenede Stater, 39401
- Hattiesburg Clinic /ID# 267860
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Missouri
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St Louis, Missouri, Forenede Stater, 63110
- Washington University /ID# 267872
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Montana
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Billings, Montana, Forenede Stater, 59102
- Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana /ID# 268185
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08901
- Rutgers Cancer Institute of New Jersey /ID# 268056
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27514
- University of North Carolina Medical Center /ID# 266879
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Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center /ID# 267966
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute - Sioux Falls /ID# 268074
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Tennessee
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Germantown, Tennessee, Forenede Stater, 38138
- West Cancer Center and Research Institute - Germantown /ID# 268619
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Texas
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Dallas, Texas, Forenede Stater, 75235
- University of Texas - Southwestern Medical Center /ID# 268241
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Houston, Texas, Forenede Stater, 77030
- The University of Texas MD Anderson Cancer Center /ID# 268098
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Houston, Texas, Forenede Stater, 77090
- Millennium Physicians /ID# 268400
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Virginia
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Charlottesville, Virginia, Forenede Stater, 22908
- University of Virginia /ID# 268108
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Haifa, Israel, 3109601
- Rambam Health Care Campus- Haifa /ID# 267739
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Jerusalem, Israel, 91120
- Hadassah Medical Center-Hebrew University /ID# 267579
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Central District
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Petah Tikva, Central District, Israel, 4941492
- Rabin Medical Center. /ID# 267740
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Tel Aviv
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Ramat Gan, Tel Aviv, Israel, 5265601
- The Chaim Sheba Medical Center /ID# 267741
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Tel Aviv, Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center /ID# 267578
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Tel Aviv, Tel Aviv, Israel, 6789140
- Assuta Medical Center - Tel Aviv /ID# 267745
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Aichi-ken
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Nagoya, Aichi-ken, Japan, 464-8681
- Aichi Cancer Center /ID# 268237
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Chiba
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Kashiwa-shi, Chiba, Japan, 277-8577
- National Cancer Center Hospital East /ID# 268236
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Osaka
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Suita-shi, Osaka, Japan, 565-0871
- The University of Osaka Hospital /ID# 268743
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Saitama
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Kitaadachi-gun, Saitama, Japan, 362-0806
- Saitama Prefectural Cancer Center /ID# 268706
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Tokyo
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Chuo-Ku, Tokyo, Japan, 104-0045
- National Cancer Center Hospital /ID# 268713
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Rio Piedras, Puerto Rico, 00935
- Pan American Center for Oncology Trials - Rio Piedras /ID# 267888
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Gyeonggido
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Seongnam-si, Gyeonggido, Sydkorea, 13620
- Seoul National University Bundang Hospital /ID# 268592
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Seoul Teugbyeolsi
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Seoul, Seoul Teugbyeolsi, Sydkorea, 03080
- Seoul National University Hospital /ID# 268719
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Seoul, Seoul Teugbyeolsi, Sydkorea, 03722
- Yonsei University Health System Severance Hospital /ID# 268718
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Seoul, Seoul Teugbyeolsi, Sydkorea, 05505
- Asan Medical Center /ID# 268717
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Seoul, Seoul Teugbyeolsi, Sydkorea, 06351
- Samsung Medical Center /ID# 268720
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Changhua City, Changhua County, Taiwan, 50006
- Changhua Christian Hospital /ID# 270464
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Kaohsiung City, Taiwan, 807
- Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 267635
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Kaohsiung City, Taiwan, 833
- Kaohsiung Chang Gung Memorial Hospital /ID# 267638
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Taichung, Taiwan, 40447
- China Medical University Hospital /ID# 267631
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Taichung, Taiwan, 407
- Taichung Veterans General Hospital /ID# 270467
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Tainan, Taiwan, 704
- National Cheng Kung University Hospital /ID# 270468
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Taipei, Taiwan, 100
- National Taiwan University Hospital /ID# 267627
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Taipei, Taiwan, 112
- Taipei Veterans General Hospital /ID# 267628
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Taoyuan City, Taiwan, 333
- Linkou Chang Gung Memorial Hospital /ID# 267637
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- Forventet levetid >= 12 uger pr. investigator-vurdering.
- Eastern Cooperative Oncology Group (ECOG) præstationsstatus (PS) på 0 eller 1 i screeningsperioden forud for den første dosis af undersøgelseslægemidlet.
- Målbar sygdom pr. responsevalueringskriterier i solide tumorer (RECIST), version 1.1.
Ekskluderingskriterier:
- Tidligere systemisk kur indeholdende c-MET-målrettet antistof eller antistoflægemiddelkonjugat (ADC).
- Anamnese med allergiske reaktioner eller overfølsomhed over for bevacizumab eller et eller flere af dets hjælpestoffer eller over for forbindelser, der ligner trifluridin/tipiracil.
- Aktiv infektion som angivet i protokollen.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Telisotuzumab Adizutecan Dose A
Participants will receive telisotuzumab adizutecan dose A, as part of the approximately 4 year study duration.
|
Intravenøs (IV) infusion
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Eksperimentel: Telisotuzumab Adizutecan Dose B
Participants will receive telisotuzumab adizutecan dose B, as part of the approximately 4 year study duration.
|
Intravenøs (IV) infusion
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of Participants with Adverse Events (AE)s
Tidsramme: Up to a Maximum of 4 Years
|
An AE is defined as any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, users or other persons whether or not related to the investigational drug.
|
Up to a Maximum of 4 Years
|
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Percentage of Participants with Clinically Significant Vital Sign Measurements as Assessed by the Investigator
Tidsramme: Up to a Maximum of 4 Years
|
Vital signs are defined as determinations of systolic and diastolic blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), and body temperature will be obtained at visits.
|
Up to a Maximum of 4 Years
|
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Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as Assessed by the Investigator
Tidsramme: Up to a Maximum of 4 Years
|
Percentage of participants with clinically significant ECGs findings as assessed by the investigator.
|
Up to a Maximum of 4 Years
|
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Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Coagulation, and Urinalysis) as Assessed by the Investigator
Tidsramme: Up to a Maximum of 4 Years
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Percentage of participants with clinically significant laboratory values (hematology, chemistry, coagulation, and urinalysis) as assessed by the investigator.
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Up to a Maximum of 4 Years
|
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Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR)
Tidsramme: Up to a Maximum of 4 Years
|
OR is defined as confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
|
Up to a Maximum of 4 Years
|
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Overall Survival (OS)
Tidsramme: Up to a Maximum of 4 Years
|
OS is defined as the time from randomization to the event of death from any cause.
|
Up to a Maximum of 4 Years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Progression Free Survival (PFS) as Assessed by BICR
Tidsramme: Up to a Maximum of 4 Years
|
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by BICR or death from any cause, whichever occurs earlier.
|
Up to a Maximum of 4 Years
|
|
OS
Tidsramme: Up to a Maximum of 4 Years
|
OS is defined as the time from randomization to the event of death from any cause
|
Up to a Maximum of 4 Years
|
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Duration of Response (DOR) as Assessed by BICR
Tidsramme: Up to a Maximum of 4 Years
|
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by BICR or death from any cause, whichever occurs first.
DOR is defined for participants with confirmed CR/PR.
|
Up to a Maximum of 4 Years
|
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Disease Control (DC) as Assessed by BICR
Tidsramme: Up to a Maximum of 4 Years
|
DC is defined as best overall response of confirmed CR or confirmed PR, or stable disease (SD) based on RECIST, version 1.1 as determined by BICR.
|
Up to a Maximum of 4 Years
|
|
OR as Assessed by Investigator
Tidsramme: Up to a Maximum of 4 Years
|
OR is defined as confirmed CR or confirmed PR as assessed by investigator per RECIST, version 1.1.
|
Up to a Maximum of 4 Years
|
|
PFS as Assessed by Investigator
Tidsramme: Up to a Maximum of 4 Years
|
PFS is defined as the time from randomization to the first occurrence of radiographic progression based on RECIST version 1.1 as determined by investigator or death from any cause, whichever occurs earlier.
|
Up to a Maximum of 4 Years
|
|
DOR as Assessed by Investigator
Tidsramme: Up to a Maximum of 4 Years
|
DOR is defined as the time from the first documented CR or PR to the first occurrence of radiographic progression per RECIST v1.1 as determined by BICR or death from any cause, whichever occurs first.
DOR is defined for participants with confirmed CR/PR.
|
Up to a Maximum of 4 Years
|
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Maximum Observed Serum (or Plasma, for Payload) Concentration (Cmax) for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Maximum observed serum (or plasma, for payload) concentration for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
|
Time to Cmax (Tmax) for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Time to Cmax for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
|
Terminal Elimination Half-Life (t1/2) for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Terminal elimination half-life for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
|
Area Under the Serum (or Plasma, for Payload) Concentration Versus Time Curve (AUC) for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Area under the serum (or plasma, for payload) concentration versus time curve will be determined using noncompartmental methods for total antibody for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
|
Antibody Drug Conjugate (ADC) for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Antibody drug conjugate for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
|
Unconjugated Topoisomerase 1 (Top1) Inhibitor Payload for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Unconjugated Top1 inhibitor payload for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
|
Incidence of Anti-Drug Antibodies (ADAs) for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Incidence of anti-drug antibodies for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
|
Neutralizing Anti-Drug Antibodies (nADAs) for Telisotuzumab Adizutecan
Tidsramme: Up to a Maximum of 4 Years
|
Neutralizing anti-drug antibodies for telisotuzumab adizutecan.
|
Up to a Maximum of 4 Years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: ABBVIE INC., AbbVie
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. november 2024
Primær færdiggørelse (Anslået)
1. august 2027
Studieafslutning (Anslået)
1. august 2027
Datoer for studieregistrering
Først indsendt
25. september 2024
Først indsendt, der opfyldte QC-kriterier
25. september 2024
Først opslået (Faktiske)
26. september 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
26. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Tarmsygdomme
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Intestinale neoplasmer
- Endetarmssygdomme
- Tyktarmssygdomme
- Kolorektale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonal, humaniseret
- Antistoffer, monoklonal
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serum globuliner
- Globuliner
- Bevacizumab
- trifluridin tipiracil lægemiddelkombination
Andre undersøgelses-id-numre
- M24-064
- 2024-512804-20-00 (Anden identifikator: EU CT)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
AbbVie er forpligtet til ansvarlig deling af data om kliniske forsøg.
Dette omfatter adgang til anonymiserede, individuelle data og data på forsøgsniveau (analysedatasæt) samt andre oplysninger.
IPD-delingstidsramme
For detaljer om, hvornår undersøgelser er tilgængelige til deling, besøg https://vivli.org/ourmember/abbvie/
IPD-delingsadgangskriterier
For at lære mere om processen eller for at indsende en anmodning, besøg følgende link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .