En studie av ALX148 med Cetuximab og Pembrolizumab for Refractory Microsatelite Stabil Metastatic Colorectal Cancer
12. august 2026 oppdatert av: University of Colorado, Denver
En fase II-studie (med sikkerhetsinnkjøring) av ALX148 i kombinasjon med Cetuximab og Pembrolizumab hos pasienter med refraktær mikrosatellittstabil metastatisk tykktarmskreft
Denne fase 2 kliniske studien vil evaluere ALX148 i kombinasjon med cetuximab og pembrolizumab for refraktær mikrosatellitt stabil metastatisk kolorektal kreft
Studieoversikt
Status
Avsluttet
Intervensjon / Behandling
Detaljert beskrivelse
Dette er en åpen, multisenter, enarms fase II klinisk studie (med sikkerhetsinnkjøring) som evaluerer kombinasjonen av ALX148, cetuximab og pembrolizumab hos pasienter med metastatisk mikrosatellittstabil kolorektal kreft som har progrediert på minst 2 linjer for systemisk terapi.
En undergruppe av pasienter vil gjennomgå studierelaterte biopsier.
Det vil være en sikkerhetsinnkjøring etterfulgt av en doseutvidelsesfase.
Pasienter i begge stadier vil fortsette å motta studieterapi til sykdomsprogresjon i henhold til RECIST v1.1.
Studietype
Intervensjonell
Registrering (Faktiske)
19
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Arizona
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Tucson, Arizona, Forente stater, 85724
- University of Arizona Cancer Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Cancer Center
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New Jersey
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New Brunswick, New Jersey, Forente stater, 08903
- Rutgers Cancer insititute
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Virginia
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Fairfax, Virginia, Forente stater, 22031
- Inova Schar Cancer Institute
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-
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
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Beskrivelse
Inklusjonskriterier:
For å være kvalifisert til å delta i denne studien, må en person oppfylle alle følgende kriterier:
- Ha en diagnose av metastatisk tykktarmskreft tidligere behandlet med minst to behandlingslinjer for uopererbar/metastatisk sykdom
- Har mikrosatellittstabil sykdom
- Tilstrekkelig hematologisk funksjon og endeorganfunksjon
Ekskluderingskriterier:
En person som oppfyller noen av følgende kriterier vil bli ekskludert fra deltakelse i denne studien:
- Pasienter med kjent MSI-høy status eller kjent mismatch reparasjonsmangel (dMMR)
- Pasienter hvor både mismatch reparasjon og mikrosatellittstabilitetsstatus er ukjent
- Anamnese med alvorlige allergiske, anafylaktiske eller andre overfølsomhetsreaksjoner på noen av studiemedisinene eller deres klasser
- Venstresidig (ved eller distalt for miltbøyningen) RAS/BRAF villtype metastatisk kolorektal kreft som er EGFR-hemmernaive.
- Tidligere behandling med et anti-PD-1-, anti-PD-L1-, anti-PD L2-, anti-CD47- eller anti-SIRPα-middel eller med et middel rettet mot en annen stimulerende eller ko-hemmende T-cellereseptor (f.eks. CTLA- 4, OX 40, CD137)
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: Ikke-randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly
Doses:
|
IV QW
Andre navn:
IV Q3W
Andre navn:
IV QW
Andre navn:
|
|
Eksperimentell: Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly
Doses:
|
IV QW
Andre navn:
IV Q3W
Andre navn:
IV QW
Andre navn:
|
|
Eksperimentell: Stage 2: Expansion cohort using recommended dose (RD) of evorpacept
Doses:
|
IV QW
Andre navn:
IV Q3W
Andre navn:
IV QW
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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)
|
|
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.
|
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 |
Tiltaksbeskrivelse |
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)
|
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.
|
For each subject, from enrollment until the end of their months-to-progression (as defined above)
|
|
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 |
Tiltaksbeskrivelse |
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).
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Wells Messersmith, MD, University of Colorado, Denver
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.
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. juli 2022
Primær fullføring (Faktiske)
30. oktober 2024
Studiet fullført (Faktiske)
30. oktober 2024
Datoer for studieregistrering
Først innsendt
27. september 2021
Først innsendt som oppfylte QC-kriteriene
9. desember 2021
Først lagt ut (Faktiske)
22. desember 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter nettsted
- Neoplasmer
- Tarmsykdommer
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Intestinale neoplasmer
- Rektale sykdommer
- Kolonsykdommer
- Kolorektale neoplasmer
- Aminosyrer, peptider og proteiner
- Proteiner
- Antistoffer, monoklonalt, humanisert
- Antistoffer, monoklonalt
- Antistoffer
- Immunoglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Cetuximab
- pembrolizumab
- ALX148
Andre studie-ID-numre
- 22-0110.cc
- AGICC-ALX148 21CRC01 (Annen identifikator: AGICC)
- NCI-2022-02019 (Annet stipend/finansieringsnummer: CTRP)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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