- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02318394
A Phase 1 Study of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
26. januar 2018 oppdatert av: MedImmune LLC
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Activity of MEDI0562 in Adult Subjects With Selected Advanced Solid Tumors
To evaluate the safety and tolerability of MEDI0562 in adult subjects with selected advanced solid tumors
Studieoversikt
Detaljert beskrivelse
This is a first-time-in-human (FTiH) Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study of MEDI0562 to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamics and preliminary anti-tumor activity in adult subjects with selected advanced solid tumors.
Studietype
Intervensjonell
Registrering (Faktiske)
56
Fase
- Fase 1
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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California
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La Jolla, California, Forente stater, 92093
- Research Site
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Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- Research Site
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Detroit, Michigan, Forente stater, 48201
- Research Site
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55404
- Research Site
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New York
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Bronx, New York, Forente stater, 10461
- Research Site
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New York, New York, Forente stater, 10032
- Research Site
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North Carolina
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Huntersville, North Carolina, Forente stater, 28078
- Research Site
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Oregon
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Portland, Oregon, Forente stater, 97213
- Research Site
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15232
- Research Site
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Texas
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Dallas, Texas, Forente stater, 75201
- Research Site
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Houston, Texas, Forente stater, 77005
- Research Site
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Seoul, Korea, Republikken, 03080
- Research Site
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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 til 99 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Subjects must have confirmed advanced solid tumor and have progressed, are refractory, or are intolerant to standard therapy appropriate for tumor type. Subjects should not have received more than 3 prior lines of therapy for recurrent or metastatic disease including both standards of care and investigational therapies.
- Subjects must have at least 1 measurable lesion.
- Consent to provide archived tumor specimens
- Willingness to undergo pre-treatment and on-treatment biopsy.
- Adequate organ function.
- Use of highly effective contraception (females) or male condom plus spermicide (males).
Exclusion Criteria:
- Prior treatment with TNFRSF agonists.
Subjects who have received certain prior immunotherapy or had toxicities relating to prior immunotherapy may not be permitted to enroll.
o Must not have required the use of additional immunosuppression other than corticosteroids for the management of an adverse event.
- History of severe allergic reactions to any unknown allergens or any components of the study drug formulations.
- Receipt of any conventional or investigational anticancer therapy within 28 days prior to the first dose of MEDI0562.
- Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment.
- Unresolved toxicities from prior anticancer therapy.
- Any condition that, in the opinion of the investigator or sponsor, would interfere with evaluation of the investigational product.
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Monotherapy Arm
MEDI0562 monotherapy
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Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Number and percentage of subjects with adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs)
Tidsramme: From time of informed consent through 12 weeks after last dose of MEDI0562
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The maximum tolerated dose/maximum administered dose will be determined by the number of participants experiencing DLTs.
The safety profile will be assessed through number of participants experiencing AEs, SAEs, abnormal laboratory parameters, vital signs and electrocardiogram (ECG) results.
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From time of informed consent through 12 weeks after last dose of MEDI0562
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Objective response rate (ORR)
Tidsramme: Estimated to be from time of informed consent up to 5 years
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The ORR is defined as the proportion of subjects with confirmed immune related (ir)CR or confirmed irPR
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Estimated to be from time of informed consent up to 5 years
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Maximum observed concentration (Cmax), area under the curve (AUC), clearance (CL) and terminal half-life of MEDI0562
Tidsramme: From first dose of MEDI0562 through to 30 days after last dose of investigational product
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The endpoints for assessment of PK of MEDI0562 include MEDI0562 concentrations in serum at different timepoints after MEDI0562 administration.
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From first dose of MEDI0562 through to 30 days after last dose of investigational product
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Number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
Tidsramme: From first dose of MEDI0562 through to 30 days after last dose of investigational product
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The immunogenicity of MEDI0562 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies (ADAs)
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From first dose of MEDI0562 through to 30 days after last dose of investigational product
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Induction of proliferation markers on various lymphocyte subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
Tidsramme: From time of informed consent through 12 weeks after last dose of investigational product
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The endpoints for assessment of pharmacodynamic activity include induction of proliferation markers in various lymphoctye subsets, immunohistochemistry of tumor biopsies and assessment of programmed death ligand 1 (PD-L1) and tumor-infiltrating lymphocyte phenotypic markers
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From time of informed consent through 12 weeks after last dose of investigational product
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Disease control rate (DCR)
Tidsramme: Estimated to be from time of informed consent up to 5 years
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The DCR is defined as the proportion of subjects with irCR, irPR, or irSD (subjects achieving irSD will be included in the DCR if they maintain irSD for ≥8 weeks)
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Estimated to be from time of informed consent up to 5 years
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Duration of response (DoR)
Tidsramme: Estimated to be from time of informed consent up to 5 years
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Duration of response will be defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.
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Estimated to be from time of informed consent up to 5 years
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Progression-free survival (PFS)
Tidsramme: Estimated to be from time of informed consent up to 5 years
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Progression-free survival will be measured from the start of treatment with MEDI0562 until the first documentation of confirmed immune-related disease progression or death due to any cause, whichever occurs first.
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Estimated to be from time of informed consent up to 5 years
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Overall survival (OS)
Tidsramme: Estimated to be from time of informed consent up to 5 years
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Overall survival will be determined as the time from the start of treatment with MEDI0562 until death due to any cause.
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Estimated to be from time of informed consent up to 5 years
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
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)
2. mars 2015
Primær fullføring (Faktiske)
9. januar 2018
Studiet fullført (Faktiske)
9. januar 2018
Datoer for studieregistrering
Først innsendt
3. desember 2014
Først innsendt som oppfylte QC-kriteriene
11. desember 2014
Først lagt ut (Anslag)
17. desember 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. januar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. januar 2018
Sist bekreftet
1. januar 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- D6060C00001
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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