Een studie om verschillende doses BI 1831169 alleen en in combinatie met Ezabenlimab te testen bij mensen met verschillende soorten gevorderde kanker (vaste tumoren)
Fase I open-label studie met dosisescalatie van BI 1831169 als monotherapie en in combinatie met ezabenlimab bij patiënten met gevorderde of gemetastaseerde vaste tumoren
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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South Australia
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Bedford Park, South Australia, Australië, 5062
- Southern Oncology Clinical Research Unit
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Victoria
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Frankston, Victoria, Australië, 3199
- Peninsula Haematology & Oncology
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Edegem, België, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, België, 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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Tübingen, Duitsland, 72076
- Universitätsklinikum Tübingen
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Ulm, Duitsland, 89081
- Universitätsklinikum Ulm
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Bordeaux, Frankrijk, 33000
- INS Bergonie
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Marseille, Frankrijk, 13385
- HOP Timone
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Rennes, Frankrijk, 35042
- CTR Eugène Marquis
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Villejuif, Frankrijk, 94805
- Institut Gustave Roussy
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Milan, Italië, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Innsbruck, Oostenrijk, 6020
- Medical University of Innsbruck
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Salzburg, Oostenrijk, 5020
- Salzburg Cancer Research Institute
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L'Hospitalet de Llobregat, Spanje, 08907
- Hospital Duran i Reynals
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Madrid, Spanje, 28040
- Fundación Jiménez Díaz
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Pamplona, Spanje, 31008
- Clínica Universidad de Navarra
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Arizona
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Gilbert, Arizona, Verenigde Staten, 85234
- Banner MD Anderson Cancer Center-Gilbert-55251
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Tucson, Arizona, Verenigde Staten, 85719
- University of Arizona
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California
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La Jolla, California, Verenigde Staten, 92037
- University of California San Diego
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Santa Monica, California, Verenigde Staten, 90404
- Providence St. John's Health Center
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Colorado
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Aurora, Colorado, Verenigde Staten, 80045
- University of Colorado Denver
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Florida
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Miami, Florida, Verenigde Staten, 33136
- University of Miami
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Orlando, Florida, Verenigde Staten, 32806
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30322
- Winship Cancer Institute
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Kentucky
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Louisville, Kentucky, Verenigde Staten, 40202
- University of Louisville
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55455
- M Health Fairview University of Minnesota Medical Center
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New Jersey
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Morristown, New Jersey, Verenigde Staten, 07960
- Morristown Medical Center
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Verenigde Staten, 29605
- Prisma Health
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Tennessee
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Nashville, Tennessee, Verenigde Staten, 37203
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
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Texas
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Houston, Texas, Verenigde Staten, 77030
- The University of Texas MD Anderson Cancer Center
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Geneva, Zwitserland, 1205
- University Hospital Geneva
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Deel 1 (Monotherapie): Arm A
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BI 1831169 |
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Experimenteel: Deel 1 (Monotherapie): Arm B
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BI 1831169 |
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Experimenteel: Deel 1 (Monotherapie): Arm C
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BI 1831169 |
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Experimenteel: Deel 2 (Combinatietherapie): Arm D
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BI 1831169 anti-PD-1 antibody |
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Experimenteel: Deel 2 (Combinatietherapie): Arm E
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BI 1831169 anti-PD-1 antibody |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
Tijdsspanne: 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)
Tijdsspanne: up to 49 months
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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
Tijdsspanne: up to 21 days
|
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)
Tijdsspanne: 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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Deel 1.1, Dosisescalatie/bevestiging: optreden van DLT’s tijdens de behandelingsperiode
Tijdsspanne: tot 49 maanden
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tot 49 maanden
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Deel 1.1, Dosisescalatie/bevestiging: optreden van bijwerkingen tijdens de behandelingsperiode
Tijdsspanne: tot 49 maanden
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tot 49 maanden
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Deel 1.2, Dosisuitbreiding: optreden van bijwerkingen tijdens de behandelingsperiode
Tijdsspanne: tot 49 maanden
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tot 49 maanden
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Deel 1.2, Dosisuitbreiding: optreden van DLT's tijdens de mono-MTD-evaluatieperiode
Tijdsspanne: tot 49 maanden
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tot 49 maanden
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Deel 2.1, Dosisescalatie/bevestiging: optreden van DLT’s tijdens de behandelingsperiode
Tijdsspanne: tot 49 maanden
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tot 49 maanden
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Deel 2.1, Dosisescalatie/bevestiging: optreden van bijwerkingen tijdens de behandelingsperiode
Tijdsspanne: tot 49 maanden
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tot 49 maanden
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Deel 2.2 – Dosisuitbreiding per indicatie, alle armen: optreden van bijwerkingen tijdens de behandelingsperiode
Tijdsspanne: tot 49 maanden
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tot 49 maanden
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Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)
Tijdsspanne: 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)
Tijdsspanne: up to 49 months
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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)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1456-0001
- 2020-003902-30 (EudraCT-nummer)
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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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