En studie för att testa olika doser av BI 1831169 ensam och i kombination med Ezabenlimab hos personer med olika typer av avancerad cancer (fasta tumörer)
Fas I öppen, dosupptrappningsstudie av BI 1831169 monoterapi och i kombination med Ezabenlimab hos patienter med avancerade eller metastaserande solida tumörer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studieorter
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South Australia
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Bedford Park, South Australia, Australien, 5062
- Southern Oncology Clinical Research Unit
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Victoria
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Frankston, Victoria, Australien, 3199
- Peninsula Haematology & Oncology
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Edegem, Belgien, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgien, 3000
- UZ Leuven
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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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Arizona
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Gilbert, Arizona, Förenta staterna, 85234
- Banner MD Anderson Cancer Center-Gilbert-55251
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Tucson, Arizona, Förenta staterna, 85719
- University of Arizona
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California
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La Jolla, California, Förenta staterna, 92037
- University of California San Diego
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Santa Monica, California, Förenta staterna, 90404
- Providence St. John's Health Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- University of Colorado Denver
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Florida
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Miami, Florida, Förenta staterna, 33136
- University of Miami
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Orlando, Florida, Förenta staterna, 32806
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Winship Cancer Institute
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Kentucky
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Louisville, Kentucky, Förenta staterna, 40202
- University of Louisville
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55455
- M Health Fairview University of Minnesota Medical Center
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New Jersey
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Morristown, New Jersey, Förenta staterna, 07960
- Morristown Medical Center
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North Carolina
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Winston-Salem, North Carolina, Förenta staterna, 27157
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37203
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
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Texas
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Houston, Texas, Förenta staterna, 77030
- The University of Texas MD Anderson Cancer Center
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Milan, Italien, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Ontario
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Toronto, Ontario, Kanada, M5G 2M9
- Princess Margaret Cancer Centre
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Geneva, Schweiz, 1205
- University Hospital Geneva
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L'Hospitalet de Llobregat, Spanien, 08907
- Hospital Duran i Reynals
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Madrid, Spanien, 28040
- Fundación Jiménez Díaz
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Pamplona, Spanien, 31008
- Clínica Universidad de Navarra
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Tübingen, Tyskland, 72076
- Universitätsklinikum Tübingen
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Ulm, Tyskland, 89081
- Universitätsklinikum Ulm
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Innsbruck, Österrike, 6020
- Medical University of Innsbruck
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Salzburg, Österrike, 5020
- Salzburg Cancer Research Institute
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
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 |
|---|---|
|
Experimentell: Del 1 (Monoterapi): Arm A
|
BI 1831169 |
|
Experimentell: Del 1 (Monoterapi): Arm B
|
BI 1831169 |
|
Experimentell: Del 1 (Monoterapi): Arm C
|
BI 1831169 |
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Experimentell: Del 2 (Kombinationsterapi): Arm D
|
BI 1831169 anti-PD-1 antibody |
|
Experimentell: Del 2 (Kombinationsterapi): Arm E
|
BI 1831169 anti-PD-1 antibody |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
Tidsram: up to 21 days
|
Part 1 (Monotherapy). |
up to 21 days
|
|
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)
Tidsram: 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
|
|
Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
Tidsram: up to 21 days
|
Part 2 (Combination Therapy). |
up to 21 days
|
|
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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Del 1.1, Dosökning/Bekräftelse: Förekomst av DLT under behandlingsperioden
Tidsram: upp till 49 månader
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upp till 49 månader
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Del 1.1, Dosökning/Bekräftelse: Förekomst av biverkningar under behandlingsperioden
Tidsram: upp till 49 månader
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upp till 49 månader
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Del 1.2, Dosexpansion: Förekomst av biverkningar under behandlingsperioden
Tidsram: upp till 49 månader
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upp till 49 månader
|
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Del 1.2, Dosexpansion: Förekomst av DLT under mono MTD-utvärderingsperioden
Tidsram: upp till 49 månader
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upp till 49 månader
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Del 2.1, Dosökning/Bekräftelse: Förekomst av DLT under behandlingsperioden
Tidsram: upp till 49 månader
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upp till 49 månader
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Del 2.1, Dosökning/Bekräftelse: Förekomst av biverkningar under behandlingsperioden
Tidsram: upp till 49 månader
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upp till 49 månader
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Del 2.2 - Dosexpansion genom indikation, alla armar: Förekomst av biverkningar under behandlingsperioden
Tidsram: upp till 49 månader
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upp till 49 månader
|
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Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)
Tidsram: up to 49 months
|
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)
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1456-0001
- 2020-003902-30 (EudraCT-nummer)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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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