Evaluering af SNDX-5613 hos deltagere med kolorektal cancer og andre solide tumorer
8. juni 2026 opdateret af: Syndax Pharmaceuticals
Et fase 1/2-studie til undersøgelse af sikkerhed, tolerabilitet, farmakokinetik, farmakodynamik og effektivitet af SNDX-5613 hos patienter med kolorektal cancer og andre solide tumorer
Denne undersøgelse vil evaluere sikkerheden, tolerabiliteten, farmakokinetikken (PK) og antitumoraktiviteten af SNDX-5613 hos deltagere med kolorektal cancer (CRC) eller andre solide tumorer, som har svigtet mindst 1 tidligere behandlingslinje.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsen vil blive gennemført i to dele.
Fase 1-delen af studiet består af en dosiseskaleringskohorte og en signalsøgende udvidelse, hvor antitumoraktivitetssignaler vil blive evalueret.
Fase 2-delen af undersøgelsen vil yderligere bekræfte antitumoraktivitetssignalerne for SNDX-5613.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
41
Fase
- Fase 2
- Fase 1
Udvidet adgang
Ikke længere tilgængelig uden for det kliniske forsøg.
Se udvidet adgangsregistrering.
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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Scottsdale, Arizona, Forenede Stater, 85258
- Honor Health Research Institute
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
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New York
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Manhattan, New York, Forenede Stater, 10065
- Memorial Sloan Kettering Cancer Center
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Ohio
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Canton, Ohio, Forenede Stater, 44718
- Gabrail Cancer Center
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt-Ingram Cancer Center
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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
Nøgleinklusionskriterier:
- Mandlige og kvindelige deltagere i alderen ≥18 år
- Deltagere med metastatisk CRC eller andre solide tumorer
- Evidens for lokalt tilbagevendende eller metastatisk sygdom baseret på billeddiagnostiske undersøgelser inden for 28 dage efter tilmelding
- CRC-deltagere skal have haft mindst én linje med standardbehandling og skal have udviklet sig på eller været intolerante over for eller ude af stand til at modtage oxaliplatin, irinotecan og bevacizumab i den fremskredne/metastatiske indstilling.
- Andre solide tumordeltagere skal have haft alle godkendte standardterapier, som er tilgængelige for deltageren, medmindre de er kontraindiceret eller utålelige.
- Deltagerne skal have oplevet dokumenteret utvetydigt progressiv sygdom ved enten RECIST v1.1 eller klinisk vurdering, eller oplevet uacceptabel toksicitet med deres tidligere behandling.
- Eastern Cooperative Oncology Group (ECOG) præstationsstatusscore på 0 til 1
- Hvis du modtager strålebehandling, har haft en 2-ugers udvaskningsperiode efter afslutning af behandlingen før modtagelse af den første dosis af undersøgelseslægemidlet og fortsætter med at have mindst 1 målbar læsion
- Mindst 42 dage siden forudgående immunterapi, inklusive tumorvacciner og checkpoint-hæmmere, og mindst 21 dage siden modtagelse af kimærisk antigenreceptorterapi eller anden modificeret T-celleterapi
- Tilstrækkelig knoglemarvs-, nyre-, hjerte- og leverfunktion
Nøgleekskluderingskriterier:
- Deltageren har en tidligere historie med ondartet tarmobstruktion, der kræver hospitalsindlæggelse i de 6 måneder før tilmelding
- Deltageren har en historie med ukontrolleret ascites, defineret som symptomatisk ascites og/eller gentagne paracenteser til symptomkontrol inden for de seneste 3 måneder
- Påviselig human immundefektvirus (HIV) viral belastning inden for de foregående 6 måneder. Deltagere med en kendt historie med HIV 1/2-antistoffer skal have testet viral load før studietilmelding
- Hepatitis B og/eller C
- Enhver af følgende inden for de 6 måneder før studiestart: myokardieinfarkt, ukontrolleret/ustabil angina, kongestiv hjertesvigt (New York Heart Association Classification Class ≥II), livstruende, ukontrolleret arytmi, cerebrovaskulær ulykke eller forbigående iskæmisk anfald
- Korrigeret QT-interval (QTc) >450 millisekunder
- Ethvert gastrointestinalt (GI) problem i den øvre mave-tarmkanal, der sandsynligvis vil påvirke oral lægemiddelabsorption eller indtagelse (f.eks. gastrisk bypass, gastroparese)
- Cirrhose med en Child-Pugh-score på B eller C
- Hjernemetastaser med undtagelse af de deltagere, der har afsluttet endelig behandling, ikke er på steroider, har en stabil neurologisk status i mindst 4 uger efter afslutning af den definitive behandling og steroider og ikke har neurologisk dysfunktion, der ville forvirre evalueringen af neurologisk og andre uønskede hændelser (AE'er)
- Anamnese med eller enhver samtidig tilstand, terapi, laboratorieabnormitet eller allergi over for hjælpestoffer, som efter efterforskerens mening kan forvirre resultaterne af undersøgelsen, forstyrre deltagerens mulighed for at deltage i hele undersøgelsens varighed eller ikke være i den bedste deltagerens interesse i at deltage
- Deltageren har modtaget tidligere kemoterapi, målrettet behandling med små molekyler eller strålebehandling inden for 2 uger før studiets baseline, eller som ikke er kommet sig (dvs. ≤grad 1 eller ved baseline) fra bivirkninger relateret til et tidligere administreret middel.
- Deltagelse i en anden terapeutisk interventionel klinisk undersøgelse, hvor et forsøgsmiddel blev administreret inden for 30 dage før start af SNDX-5613
- Deltageren har modtaget en transfusion af blodprodukter eller administration af kolonistimulerende faktorer inden for 4 uger efter den første dosis af undersøgelseslægemidlet
- Deltageren har en anden kendt yderligere malignitet, som skrider frem eller kræver aktiv behandling (undtagen tilstrækkeligt behandlet basalcellecarcinom, pladecelle i huden, cervikal intraepitelial neoplasi/cervikal carcinom in situ eller melanom in situ eller duktalt carcinom in situ af brystet). Tidligere kræftsygdomme er tilladt, hvis der ikke er nogen aktiv sygdom inden for de foregående 5 år
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 |
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Aktiv komparator: Fase 2: Kemoterapi
Deltagerne vil modtage kemoterapi fra dag 1 i hver 28-dages cyklus.
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Enten Lonsurf® eller Stivarga® administreret efter investigatorens valg i den respektive lægemiddelmærkes dosis og tidsplan.
Deltagerne kan fortsætte med at modtage behandling indtil sygdomsprogression eller indtil de oplever uacceptabel toksicitet.
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Eksperimentel: Fase 1a: Dosiseskalering
Deltagerne vil modtage revumenib-tabletter eller -kapsler tre gange om dagen (TID) eller to gange om dagen (BID) fra dag 1 i hver 28-dages cyklus.
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Revumenib indgivet oralt med eller uden mad.
Deltagerne kan fortsætte med at modtage behandling indtil sygdomsprogression eller indtil de oplever uacceptabel toksicitet.
Andre navne:
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Eksperimentel: Fase 1b: Signalsøgning
Deltagerne vil modtage revumenib-tabletter TID eller BID fra dag 1 i hver 28-dages cyklus.
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Revumenib indgivet oralt med eller uden mad.
Deltagerne kan fortsætte med at modtage behandling indtil sygdomsprogression eller indtil de oplever uacceptabel toksicitet.
Andre navne:
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Eksperimentel: Fase 2: Revumenib
Deltagerne vil modtage revumenib-tabletter TID eller BID fra dag 1 i hver 28-dages cyklus.
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Revumenib indgivet oralt med eller uden mad.
Deltagerne kan fortsætte med at modtage behandling indtil sygdomsprogression eller indtil de oplever uacceptabel toksicitet.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Phase 1a: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Tidsramme: Day 1 up to Day 28
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DLT was defined as any of the following occurring in Cycle 1: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cells/mm^3) unresolved to Grade 2 (ANC >1500 cells/mm^3) or baseline for more than 7 consecutive days in the absence of growth factor support, ≥Grade 3 neutropenia (ANC <1000 cells/mm^3) with a single temperature of >38.3°Celsius (101°Fahrenheit) or a sustained temperature of ≥38°Celsius (100.4°Fahrenheit) for more than 1 hour, Grade 4 thrombocytopenia (<25,000/mm^3) of any duration, ≥Grade 3 thrombocytopenia (<50,000/mm^3) with clinically significant bleeding, Grade 4 anemia (i.e, life-threatening consequences; urgent intervention indicated) or ≥Grade 3 nonhematologic toxicity as defined in Common Terminology Criteria for Adverse Events version 5.0 scale where Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, medically significant, Grade 4=Life-threatening and 5=Death.
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Day 1 up to Day 28
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Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Tidsramme: Up to 2.2 years
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An adverse event (AE) was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
TEAEs were defined as those having an onset on or after the first dose of revumenib or a sign, symptom, or a diagnosis that worsened on or after first dose of revumenib but no later than 30 days after the date of the last dose of revumenib.
A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
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Up to 2.2 years
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Phase 1: Disease Control Rate (DCR)
Tidsramme: Up to 2.2 years
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DCR was defined as the percentage of participants with objective evidence of confirmed complete response (CR), confirmed partial response (PR), or stable disease (SD) according to Response Evaluation in Solid Tumors (RECIST) version 1.1 criteria as assessed by the investigator.
CR=disappearance of all target lesions; disappearance of non-target lesions.
PR=At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
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Up to 2.2 years
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Phase 1: Overall Response Rate (ORR)
Tidsramme: Up to 2.2 years
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ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by the investigator.
PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
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Up to 2.2 years
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Phase 2: Progression Free Survival (PFS)
Tidsramme: Up to 2.2 years
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PFS was defined as the time from the first dosing date to the first documented progression or death due to any cause, whichever occurred first.
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Up to 2.2 years
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Phase 1a: Maximum Plasma Concentration (Cmax) of Revumenib
Tidsramme: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
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Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
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Phase 1b: Maximum Plasma Concentration (Cmax) of Revumenib
Tidsramme: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
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Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
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Phase 1a: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Tidsramme: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
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Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
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Phase 1a: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Tidsramme: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
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Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15, Cycle 5 Day 1 (Cycle length=28 days)
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Phase 1b: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Tidsramme: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
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Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
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Phase 1b: Area Under the Plasma Concentration Versus Time Curve (AUC0-t) of Revumenib
Tidsramme: Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
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Cycle 1 Day 7, Cycle 1 Day 14, Cycle 2 Day 8, Cycle 2 Day 15 (Cycle length=28 days)
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Phase 2: Area Under The Concentration Time Curve of Revumenib
Tidsramme: Up to 2.2 years
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Up to 2.2 years
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Phase 2: Maximum Plasma Concentration (Cmax) of Revumenib
Tidsramme: Up to 2.2 years
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Up to 2.2 years
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Phase 2: Time to Maximum Plasma Concentration (Tmax) of Revumenib
Tidsramme: Up to 2.2 years
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Up to 2.2 years
|
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Phase 2: Number of Participants With TEAEs
Tidsramme: Up to 2.2 years
|
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment.
An AE was therefore any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
TEAEs were defined as those having an onset on or after the first dose of revumenib or a sign, symptom, or a diagnosis that worsened on or after first dose of revumenib but no later than 30 days after the date of the last dose of revumenib.
A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
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Up to 2.2 years
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Phase 2: Overall Survival (OS)
Tidsramme: Up to 2.2 years
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OS was defined as the time from the date of first dosing of revumenib to death due to any cause.
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Up to 2.2 years
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Phase 2: Disease Control Rate (DCR) at 6 Cycles (28-Day Cycles) as Assessed by Blinded Radiographic Review
Tidsramme: Up to 2.2 years
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DCR was defined as the percentage of participants with objective evidence of confirmed CR, confirmed PR, or SD according to RECIST version 1.1 criteria as assessed by blinded radiographic review.
CR=disappearance of all target lesions; disappearance of non-target lesions.
PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
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Up to 2.2 years
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Phase 2: ORR as Assessed by Blinded Radiographic Review
Tidsramme: Up to 2.2 years
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ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by blinded radiographic review.
PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
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Up to 2.2 years
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Phase 2: Duration of Response (DOR) as Assessed by Blinded Radiographic Review
Tidsramme: Up to 2.2 years
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DOR was defined as the time from the first documented response (CR or PR) to the first documented objective PD or death due to any case according to RECIST v1.1 criteria as assessed by blinded radiographic review.
PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
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Up to 2.2 years
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Phase 2: Disease Control Rate (DCR) at 6 Cycles (28-Day Cycles) as Assessed by the Investigator
Tidsramme: Up to 2.2 years
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DCR was defined as the percentage of participants with objective evidence of confirmed CR, confirmed PR, or SD according to RECIST version 1.1 criteria as assessed by investigator.
CR=disappearance of all target lesions; disappearance of non-target lesions.
PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
SD=Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
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Up to 2.2 years
|
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Phase 2: Overall Response Rate (ORR) as Assessed by the Investigator
Tidsramme: Up to 2.2 years
|
ORR was defined as the percentage of participants who achieved a best overall response of PR or CR according to RECIST v1.1 criteria as assessed by investigator.
PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
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Up to 2.2 years
|
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Phase 2: DOR as Assessed by the Investigator
Tidsramme: Up to 2.2 years
|
DOR was defined as the time from the first documented response (CR or PR) to the first documented objective PD or death due to any case according to RECIST v1.1 criteria as assessed by investigator.
PR=At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD.
CR=Disappearance of all target lesions; disappearance of all nontarget lesions.
PD=At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; appearance of one or more new lesions and/or unequivocal progression of existing nontarget lesions.
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Up to 2.2 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
4. april 2023
Primær færdiggørelse (Faktiske)
30. juni 2025
Studieafslutning (Faktiske)
30. juni 2025
Datoer for studieregistrering
Først indsendt
7. februar 2023
Først indsendt, der opfyldte QC-kriterier
15. februar 2023
Først opslået (Faktiske)
16. februar 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SNDX-5613-0706
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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