Une étude visant à tester différentes doses de BI 1831169 seul et en association avec l'ezabenlimab chez des personnes atteintes de différents types de cancer avancé (tumeurs solides)
Essai ouvert de phase I avec escalade de dose du BI 1831169 en monothérapie et en association avec l'ezabenlimab chez des patients atteints de tumeurs solides avancées ou métastatiques
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Tübingen, Allemagne, 72076
- Universitätsklinikum Tübingen
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Ulm, Allemagne, 89081
- Universitätsklinikum Ulm
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South Australia
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Bedford Park, South Australia, Australie, 5062
- Southern Oncology Clinical Research Unit
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Victoria
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Frankston, Victoria, Australie, 3199
- Peninsula Haematology & Oncology
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Edegem, Belgique, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgique, 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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L'Hospitalet de Llobregat, Espagne, 08907
- Hospital Duran i Reynals
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Madrid, Espagne, 28040
- Fundación Jiménez Díaz
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Pamplona, Espagne, 31008
- Clínica Universidad de Navarra
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Bordeaux, France, 33000
- INS Bergonie
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Marseille, France, 13385
- HOP Timone
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Rennes, France, 35042
- CTR Eugène Marquis
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Villejuif, France, 94805
- Institut Gustave Roussy
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Milan, Italie, 20162
- ASST Grande Ospedale Metropolitano Niguarda
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Innsbruck, L'Autriche, 6020
- Medical University of Innsbruck
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Salzburg, L'Autriche, 5020
- Salzburg Cancer Research Institute
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Geneva, Suisse, 1205
- University Hospital Geneva
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Arizona
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Gilbert, Arizona, États-Unis, 85234
- Banner MD Anderson Cancer Center-Gilbert-55251
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Tucson, Arizona, États-Unis, 85719
- University of Arizona
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California
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La Jolla, California, États-Unis, 92037
- University of California San Diego
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Santa Monica, California, États-Unis, 90404
- Providence St. John's Health Center
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Colorado
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Aurora, Colorado, États-Unis, 80045
- University of Colorado Denver
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Florida
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Miami, Florida, États-Unis, 33136
- University of Miami
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Orlando, Florida, États-Unis, 32806
- Orlando Health Cancer Institute
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Georgia
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Atlanta, Georgia, États-Unis, 30322
- Winship Cancer Institute
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Kentucky
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Louisville, Kentucky, États-Unis, 40202
- University of Louisville
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- M Health Fairview University of Minnesota Medical Center
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New Jersey
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Morristown, New Jersey, États-Unis, 07960
- Morristown Medical Center
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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South Carolina
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Greenville, South Carolina, États-Unis, 29605
- Prisma Health
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Tennessee
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Nashville, Tennessee, États-Unis, 37203
- Tennessee Oncology, PLLC - Elliston Place Plaza DDU
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Texas
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Houston, Texas, États-Unis, 77030
- The University of Texas MD Anderson Cancer Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Partie 1 (monothérapie) : bras A
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BI 1831169 |
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Expérimental: Partie 1 (monothérapie) : bras B
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BI 1831169 |
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Expérimental: Partie 1 (monothérapie) : bras C
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BI 1831169 |
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Expérimental: Partie 2 (Thérapie combinée) : Bras D
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BI 1831169 anti-PD-1 antibody |
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Expérimental: Partie 2 (Thérapie combinée) : Bras E
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BI 1831169 anti-PD-1 antibody |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Partie 1.1, Augmentation de dose/Confirmation : apparition de DLT pendant la période de traitement
Délai: jusqu'à 49 mois
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jusqu'à 49 mois
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Partie 1.1, Augmentation de dose/Confirmation : apparition d'événements indésirables pendant la période de traitement
Délai: jusqu'à 49 mois
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jusqu'à 49 mois
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Partie 1.2, Expansion de la dose : apparition d'événements indésirables pendant la période de traitement
Délai: jusqu'à 49 mois
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jusqu'à 49 mois
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Partie 1.2, Expansion de dose : apparition de DLT pendant la période d'évaluation mono MTD
Délai: jusqu'à 49 mois
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jusqu'à 49 mois
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Partie 2.1, Augmentation de dose/Confirmation : apparition de DLT pendant la période de traitement
Délai: jusqu'à 49 mois
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jusqu'à 49 mois
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Partie 2.1, Augmentation de dose/Confirmation : apparition d'événements indésirables pendant la période de traitement
Délai: jusqu'à 49 mois
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jusqu'à 49 mois
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|
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Partie 2.2 - Expansion de la dose par indication, tous les bras : survenue d'événements indésirables pendant la période de traitement
Délai: jusqu'à 49 mois
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jusqu'à 49 mois
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Part 2.2 - Dose Expansion by Indication, Arms D and E: Duration of objective response (DoR)
Délai: 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)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 1456-0001
- 2020-003902-30 (Numéro EudraCT)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
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).
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