En undersøgelse af ALX148 med Cetuximab og Pembrolizumab til refraktær mikrosatellitstabil metastatisk kolorektal cancer
12. august 2026 opdateret af: University of Colorado, Denver
Et fase II-studie (med sikkerhedsindkøring) af ALX148 i kombination med Cetuximab og Pembrolizumab hos patienter med refraktær mikrosatellitstabil metastatisk kolorektal cancer
Dette fase 2 kliniske studie vil evaluere ALX148 i kombination med cetuximab og pembrolizumab for refraktær mikrosatellit stabil metastatisk kolorektal cancer
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Dette er et åbent, multicenter, enkeltarms fase II klinisk forsøg (med sikkerhedsindkøring), der evaluerer kombinationen af ALX148, cetuximab og pembrolizumab hos patienter med metastatisk mikrosatellitstabil kolorektal cancer, som har udviklet sig på mindst 2 linjer af systemisk terapi.
En undergruppe af patienter vil gennemgå undersøgelsesrelaterede biopsier.
Der vil være et sikkerhedsindkøringstrin efterfulgt af et dosisudvidelsestrin.
Patienter i begge stadier vil fortsætte med at modtage undersøgelsesterapi indtil sygdomsprogression i henhold til RECIST v1.1.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85724
- University of Arizona Cancer Center
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- University of Colorado Cancer Center
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New Jersey
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New Brunswick, New Jersey, Forenede Stater, 08903
- Rutgers Cancer insititute
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Virginia
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Fairfax, Virginia, Forenede Stater, 22031
- Inova Schar Cancer Institute
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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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
For at være berettiget til at deltage i denne undersøgelse skal en person opfylde alle følgende kriterier:
- Har en diagnose af metastatisk kolorektal cancer tidligere behandlet med mindst to behandlingslinjer for inoperabel/metastatisk sygdom
- Har mikrosatellit stabil sygdom
- Tilstrækkelig hæmatologisk funktion og endeorganfunktion
Ekskluderingskriterier:
En person, der opfylder et af følgende kriterier, vil blive udelukket fra deltagelse i denne undersøgelse:
- Patienter med kendt MSI-høj status eller kendt mismatch reparationsmangel (dMMR)
- Patienter, hvor både mismatch-reparation og mikrosatellitstabilitetsstatus er ukendt
- Anamnese med alvorlige allergiske, anafylaktiske eller andre overfølsomhedsreaktioner over for nogen af undersøgelsesmedicinen eller deres klasser
- Venstresidet (ved eller distalt for miltbøjningen) RAS/BRAF vildtype metastatisk kolorektal cancer, som er EGFR-hæmmer-naive.
- Forudgående terapi med et anti-PD-1, anti-PD-L1, anti PD L2, anti-CD47 eller anti-SIRPα middel eller med et middel rettet mod en anden stimulerende eller co-hæmmende T-cellereceptor (f.eks. CTLA- 4, OX 40, CD137)
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: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly
Doses:
|
IV QW
Andre navne:
IV Q3W
Andre navne:
IV QW
Andre navne:
|
|
Eksperimentel: Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly
Doses:
|
IV QW
Andre navne:
IV Q3W
Andre navne:
IV QW
Andre navne:
|
|
Eksperimentel: Stage 2: Expansion cohort using recommended dose (RD) of evorpacept
Doses:
|
IV QW
Andre navne:
IV Q3W
Andre navne:
IV QW
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Objective Response Rate (ORR)
Tidsramme: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
|
A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent)
|
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Determine the Recommended Dose (RD) of Evorpacept (ALX148) in Combination With Cetuximab and Pembrolizumab
Tidsramme: During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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The recommended dose (RD) of evorpacept was determined by evaluating the totality of the first-cycle clinical data.
Rules to determine the RD based on the number of patients experiencing a dose-limiting toxicity (DLT) were defined in the protocol.
|
During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Duration Of Response (DOR)
Tidsramme: From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
|
DOR is defined as the length of time (months) from the 1st response (CR or PR per RECIST v1.1) until either the first observation of progressive disease (PD) or death from any cause.
Patients who did not experience PD or die are considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
This is a subgroup analysis, consisting of all patients who experienced response (CR or PR per RECIST v1.1)
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From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
|
|
Progression-Free Survival (PFS)
Tidsramme: For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
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For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
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Overall Survival (OS)
Tidsramme: For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
|
For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
|
Disease Control Rate (DCR)
Tidsramme: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PFS - Response-Evaluable Population
Tidsramme: For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
Months-to-Progression is defined as the length of time (in months) from enrollment until either the first observation of progressive disease (PD) using RECIST v1.1 or death from any cause.
Patients who did not have PD or die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
PFS is a survival analysis involving both the binary endpoint of whether or not each patient progressed or not (i.e. were censored), and the months-to-progression times for each patient.
|
For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
|
OS - Response-Evaluable Population
Tidsramme: For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
Months-to-death is defined as the number of months from enrollment until death from any cause.
Subjects who did not die will be considered to be censored at the latest date they are confirmed to be alive, which is the most recent of their discontinuation date or latest follow-up date.
OS is a survival analysis involving both the binary endpoint of whether or not each patient died or not, and the months-to-death times for each patient.
|
For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
|
ORR - Response-Evaluable Population
Tidsramme: The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
A patient is considered to be an objective responder if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR) or partial response (PR) per RECIST v1.1.
ORR is defined as the proportion of patients who were classified as objective responders.
|
The duration of time during which tumor assessments were performed for each patient, until they experience disease progression. The latest timepoint an assessment was performed was at Cycle 21 Day 15 (14.5 mo after informed consent).
|
|
DCR - Response-Evaluable Population
Tidsramme: The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
A patient is classified as 'Disease Controlled' if their best overall response (BOR) of their follow-up tumor assessments was assessed to be complete response (CR), partial response (PR), or stable disease (SD) per RECIST v1.1.
DCR is defined as the proportion of patients who were classified as 'Disease Controlled'.
|
The duration of time during which tumor assessments were performed for each individual patient. Per protocol, assessments will continue until disease progression. The latest assessment was performed at Cycle 21, Day 15 (14.5 mo after informed consent).
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Wells Messersmith, MD, University of Colorado, Denver
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.
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)
28. juli 2022
Primær færdiggørelse (Faktiske)
30. oktober 2024
Studieafslutning (Faktiske)
30. oktober 2024
Datoer for studieregistrering
Først indsendt
27. september 2021
Først indsendt, der opfyldte QC-kriterier
9. december 2021
Først opslået (Faktiske)
22. december 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
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
- Cetuximab
- pembrolizumab
- ALX148
Andre undersøgelses-id-numre
- 22-0110.cc
- AGICC-ALX148 21CRC01 (Anden identifikator: AGICC)
- NCI-2022-02019 (Andet bevillings-/finansieringsnummer: CTRP)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .