En studie av ALX148 med Cetuximab och Pembrolizumab för Refractory Microsatellite Stabil Metastatic Colorectal Cancer
12 augusti 2026 uppdaterad av: University of Colorado, Denver
En fas II-studie (med säkerhetsinkörning) av ALX148 i kombination med Cetuximab och Pembrolizumab hos patienter med refraktär mikrosatellitstabil metastatisk kolorektal cancer
Denna kliniska fas 2-studie kommer att utvärdera ALX148 i kombination med cetuximab och pembrolizumab för refraktär mikrosatellitstabil metastaserad kolorektal cancer
Studieöversikt
Status
Avslutad
Intervention / Behandling
Detaljerad beskrivning
Detta är en öppen, multicenter, enarmad fas II-studie (med säkerhetsinkörning) som utvärderar kombinationen av ALX148, cetuximab och pembrolizumab hos patienter med metastaserad mikrosatellitstabil kolorektal cancer som har utvecklats på minst 2 systemisk terapi.
En undergrupp av patienter kommer att genomgå studierelaterade biopsier.
Det kommer att finnas ett säkerhetsinkörningssteg följt av ett dosexpansionssteg.
Patienter i båda stadierna kommer att fortsätta att få studieterapi tills sjukdomsprogression enligt RECIST v1.1.
Studietyp
Interventionell
Inskrivning (Faktisk)
19
Fas
- Fas 2
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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Arizona
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Tucson, Arizona, Förenta staterna, 85724
- University of Arizona Cancer Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Cancer Center
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New Jersey
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New Brunswick, New Jersey, Förenta staterna, 08903
- Rutgers Cancer insititute
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Virginia
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Fairfax, Virginia, Förenta staterna, 22031
- Inova Schar Cancer Institute
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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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Beskrivning
Inklusionskriterier:
För att vara berättigad att delta i denna studie måste en individ uppfylla alla följande kriterier:
- Ha en diagnos av metastaserad kolorektal cancer som tidigare behandlats med minst två behandlingslinjer för inoperabel/metastaserande sjukdom
- Har mikrosatellitstabil sjukdom
- Tillräcklig hematologisk funktion och ändorgansfunktion
Exklusions kriterier:
En person som uppfyller något av följande kriterier kommer att uteslutas från att delta i denna studie:
- Patienter med känd MSI-hög status eller känd missmatch reparationsbrist (dMMR)
- Patienter hos vilka både felmatchningsreparation och mikrosatellitstabilitetsstatus är okänd
- Anamnes med allvarliga allergiska, anafylaktiska eller andra överkänslighetsreaktioner mot någon av studieläkemedlen eller deras klasser
- Vänstersidig (vid eller distalt till mjältböjningen) RAS/BRAF metastaserad kolorektalcancer av vildtyp som är EGFR-hämmare naiva.
- Tidigare terapi med ett anti-PD-1-, anti-PD-L1-, anti-PD L2-, anti-CD47- eller anti-SIRPα-medel eller med ett medel riktat mot en annan stimulerande eller samhämmande T-cellsreceptor (t.ex. CTLA- 4, OX 40, CD137)
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: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Stage 1: Safety run-in evaluating evorpacept at 15 mg/kg weekly
Doses:
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IV QW
Andra namn:
IV Q3W
Andra namn:
IV QW
Andra namn:
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Experimentell: Stage 1: Safety run-in evaluating evorpacept at 10 mg/kg weekly
Doses:
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IV QW
Andra namn:
IV Q3W
Andra namn:
IV QW
Andra namn:
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Experimentell: Stage 2: Expansion cohort using recommended dose (RD) of evorpacept
Doses:
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IV QW
Andra namn:
IV Q3W
Andra namn:
IV QW
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Objective Response Rate (ORR)
Tidsram: 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
Tidsram: 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.
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During the safety run-in, each patient must have completed at least the 1st cycle (3 weeks) of treatment.
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Duration Of Response (DOR)
Tidsram: From date of 1st response (CR or PR) until either progression (PD or death) or censoring date
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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
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Progression-Free Survival (PFS)
Tidsram: For each subject, from enrollment until the end of their months-to-progression (as defined above)
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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)
Tidsram: 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.
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For each subject, from enrollment until the end of their months-to-death time (as defined above)
|
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Disease Control Rate (DCR)
Tidsram: 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).
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
PFS - Response-Evaluable Population
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Wells Messersmith, MD, University of Colorado, Denver
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.
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 juli 2022
Primärt slutförande (Faktisk)
30 oktober 2024
Avslutad studie (Faktisk)
30 oktober 2024
Studieregistreringsdatum
Först inskickad
27 september 2021
Först inskickad som uppfyllde QC-kriterierna
9 december 2021
Första postat (Faktisk)
22 december 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Tarmsjukdomar
- Gastrointestinala neoplasmer
- Neoplasmer i matsmältningssystemet
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Intestinala neoplasmer
- Rektala sjukdomar
- Kolonsjukdomar
- Kolorektala neoplasmer
- Aminosyror, peptider och proteiner
- Proteiner
- Antikroppar, monoklonal, humaniserad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Cetuximab
- pembrolizumab
- Alx148
Andra studie-ID-nummer
- 22-0110.cc
- AGICC-ALX148 21CRC01 (Annan identifierare: AGICC)
- NCI-2022-02019 (Annat bidrag/finansieringsnummer: CTRP)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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