En studie for å teste forskjellige doser av BI 1831169 alene og i kombinasjon med Ezabenlimab hos personer med forskjellige typer avansert kreft (faste svulster)
Fase I åpent, doseeskaleringsforsøk av BI 1831169 monoterapi og i kombinasjon med Ezabenlimab hos pasienter med avanserte eller metastatiske solide svulster
This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time.
This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle.
Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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South Australia
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Bedford Park, South Australia, Australia, 5062
- Southern Oncology Clinical Research Unit
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Victoria
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Frankston, Victoria, Australia, 3199
- Peninsula Haematology & Oncology
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Edegem, Belgia, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgia, 3000
- UZ Leuven
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Centre
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Arizona
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Gilbert, Arizona, Forente stater, 85234
- Banner MD Anderson Cancer Center-Gilbert-55251
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Tucson, Arizona, Forente stater, 85719
- University of Arizona
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California
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La Jolla, California, Forente stater, 92037
- University of California San Diego
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Santa Monica, California, Forente stater, 90404
- Providence St. John's Health Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- University of Colorado Denver
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Florida
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Miami, Florida, Forente stater, 33136
- University of Miami
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Orlando, Florida, Forente stater, 32806
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, Forente stater, 30322
- Winship Cancer Institute
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Kentucky
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Louisville, Kentucky, Forente stater, 40202
- University of Louisville
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- M Health Fairview University of Minnesota Medical Center
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New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Morristown Medical Center
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27157
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Forente stater, 29605
- Prisma Health
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
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Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas MD Anderson Cancer Center
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Bordeaux, Frankrike, 33000
- INS Bergonie
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Marseille, Frankrike, 13385
- HOP Timone
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Rennes, Frankrike, 35042
- CTR Eugène Marquis
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Villejuif, Frankrike, 94805
- Institut Gustave Roussy
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Milan, Italia, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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L'Hospitalet de Llobregat, Spania, 08907
- Hospital Duran i Reynals
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Madrid, Spania, 28040
- Fundación Jiménez Díaz
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Pamplona, Spania, 31008
- Clínica Universidad de Navarra
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Geneva, Sveits, 1205
- University Hospital Geneva
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Tübingen, Tyskland, 72076
- Universitätsklinikum Tübingen
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Ulm, Tyskland, 89081
- Universitätsklinikum Ulm
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Innsbruck, Østerrike, 6020
- Medical University of Innsbruck
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Salzburg, Østerrike, 5020
- Salzburg Cancer Research Institute
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced, unresectable and/or metastatic or relapsed/refractory solid tumors
- At least one or two accessible lesions, one with a minimum lesion diameter for injection of BI 1831169 (where applicable), and one which is amenable to biopsy (where applicable). Lesions must either be easily accessible or, if not easily accessible, patient must be willing to undergo repeated procedures (e.g., image guided procedures) for both biopsies and injections of BI 1831169
- Has failed conventional treatment or for whom no therapy of proven efficacy exists, who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. This criterion does not apply to the specific indications in Part 2.
Further inclusion criteria apply.
Exclusion Criteria:
- Previous treatment with Vesicular stomatitis virus (VSV)-based agents
- Concomitant medication or condition considered a high risk for complications from injection or biopsy as per the Investigator's judgement
- Presence of brain metastases
- Presence of Human Immunodeficiency Virus (HIV) meeting certain criteria, active autoimmune disease or chronic active infection (Hepatitis C or B virus (HCV/HBV))
- Chronic steroid use, regardless of daily dose Further exclusion criteria apply.
Studieplan
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 |
|---|---|
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Eksperimentell: Del 1 (monoterapi): Arm A
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BI 1831169 |
|
Eksperimentell: Del 1 (monoterapi): Arm B
|
BI 1831169 |
|
Eksperimentell: Del 1 (Monoterapi): Arm C
|
BI 1831169 |
|
Eksperimentell: Del 2 (Kombinasjonsterapi): Arm D
|
BI 1831169 anti-PD-1 antibody |
|
Eksperimentell: Del 2 (Kombinasjonsterapi): Arm E
|
BI 1831169 anti-PD-1 antibody |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
Tidsramme: up to 21 days
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Part 1 (Monotherapy). |
up to 21 days
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Part 1.2, Dose expansion: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR)
Tidsramme: up to 49 months
|
BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST). BOR will consider all tumor assessments from first administration of trial medication until disease progression or death (whichever occurs first) or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent. |
up to 49 months
|
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Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
Tidsramme: up to 21 days
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Part 2 (Combination Therapy). |
up to 21 days
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Part 2.2, Dose Expansion: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed partial response (iPR)
Tidsramme: up to 49 months
|
BOR is defined according to Response Criteria for Intratumoral Immunotherapy in Solid Tumors (itRECIST) by Investigator's assessment. BOR will consider all tumor assessments from first administration of trial medication until disease progression, death, last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent (whichever occurs first). |
up to 49 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Del 1.1, Doseeskalering/bekreftelse: Forekomst av DLT i løpet av behandlingsperioden
Tidsramme: opptil 49 måneder
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opptil 49 måneder
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Del 1.1, Doseeskalering/Bekreftelse: Forekomst av uønskede hendelser i løpet av behandlingsperioden
Tidsramme: opptil 49 måneder
|
opptil 49 måneder
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Del 1.2, Doseutvidelse: Forekomst av uønskede hendelser i løpet av behandlingsperioden
Tidsramme: opptil 49 måneder
|
opptil 49 måneder
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Del 1.2, Doseutvidelse: Forekomst av DLT i løpet av mono MTD-evalueringsperioden
Tidsramme: opptil 49 måneder
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opptil 49 måneder
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Del 2.1, Doseeskalering/bekreftelse: Forekomst av DLT i løpet av behandlingsperioden
Tidsramme: opptil 49 måneder
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opptil 49 måneder
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Del 2.1, Doseeskalering/Bekreftelse: Forekomst av uønskede hendelser i løpet av behandlingsperioden
Tidsramme: opptil 49 måneder
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opptil 49 måneder
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Del 2.2 - Doseutvidelse etter indikasjon, alle armer: Forekomst av uønskede hendelser i løpet av behandlingsperioden
Tidsramme: opptil 49 måneder
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opptil 49 måneder
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Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)
Tidsramme: up to 49 months
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DoR is defined as the time from first documented iCR or iPR according to iRECIST until the earliest of disease progression by Investigator's assessment or death among patients with OR. |
up to 49 months
|
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Part 2.2, Dose Expansion by Indication, Arms D and E: Disease control (DC)
Tidsramme: up to 49 months
|
DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST by Investigator's assessment. |
up to 49 months
|
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Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months (PFS-4)
Tidsramme: up to 4 months
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PFS-4 is defined as the proportion of patients who are alive and without progression by 4 months from the start of treatment. PFS is assessed by the Investigator using iRECIST. |
up to 4 months
|
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Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
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Oppdateringer av studieposter
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Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1456-0001
- 2020-003902-30 (EudraCT-nummer)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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