A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)
- Registration Number
- NCT05155332
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 190
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 2 (Combination therapy): Arm F BI 1831169 - Part 2 (Combination therapy): Arm G anti-PD-1 antibody - Part 2 (Combination therapy): Arm E anti-PD-1 antibody - Part 2 (Combination therapy): Arm G BI 1831169 - Part 1 (Monotherapy): Arm B BI 1831169 - Part 2 (Combination therapy): Arm D anti-PD-1 antibody - Part 2 (Combination therapy): Arm E BI 1831169 - Part 2 (Combination therapy): Arm F anti-PD-1 antibody - Part 1 (Monotherapy): Arm A BI 1831169 - Part 1 (Monotherapy): Arm C BI 1831169 - Part 2 (Combination therapy): Arm D BI 1831169 -
- Primary Outcome Measures
Name Time Method Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period up to 21 days Part 1 (Monotherapy).
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) 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.Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period up to 21 days Part 2 (Combination Therapy).
Part 2.2, Dose Expansion, Arm D: Objective response (OR) defined as best overall response (BOR) of confirmed intratumoral immunotherapy complete response (itCR) or confirmed intratumoral immunotherapy partial response (itPR) 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.Part 2.2, Dose Expansion, Arm E, Arm F, Arm G: Objective response (OR) defined as best overall response (BOR) of confirmed immunotherapy complete response (iCR) or confirmed immunotherapy partial response (iPR) up to 49 months BOR is defined according to Response Criteria for intravenous Immunotherapy in Solid Tumors (iRECIST).
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.
- Secondary Outcome Measures
Name Time Method Part 1.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period up to 49 months Part 1.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period up to 49 months Part 1.2, Dose expansion: Occurrence of adverse events during the on-treatment period up to 49 months Part 1.2, Dose expansion: Occurrence of DLTs during the mono MTD evaluation period up to 49 months Part 2.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period up to 49 months Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period up to 49 months Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period up to 49 months Part 2.2 - Dose Expansion by Indication, Arm D: Duration of objective response (DoR) up to 49 months DoR is defined as the time from first documented itCR or itPR according to modified itRECIST until the earliest of disease progression or death among patients with OR.
Part 2.2, Dose Expansion by Indication, Arm D: Disease control (DC) up to 49 months DC is defined as a BOR itCR, itPR or intratumoral immunotherapy stable disease (itSD), with BOR defined according to modified itRECIST.
Part 2.2, Dose Expansion by Indication, Arms E, F, G: Duration of objective response (DoR) 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 or death among patients with OR.
Part 2.2, Dose Expansion by Indication, Arms E, F, G: Disease control (DC) up to 49 months DC is defined as a BOR of iCR, iPR or immunotherapy stable disease (iSD), with BOR defined according to iRECIST.
Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months up to 4 months PFS rate at 4 months (PFS-4) according to iRECIST is defined as the proportion of patients who are alive and without progression by 4 months from the start of treatment.
Trial Locations
- Locations (34)
Salzburg Cancer Research Institute
🇦🇹Salzburg, Austria
Hospital Quiron. I.C.U.
🇪🇸Barcelona, Spain
Banner MD Anderson Cancer Center-Gilbert-55251
🇺🇸Gilbert, Arizona, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of California Irvine
🇺🇸Orange, California, United States
Providence St. John's Health Center
🇺🇸Santa Monica, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
M Health Fairview University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Southern Oncology Clinical Research Unit
🇦🇺Bedford Park, South Australia, Australia
Peninsula Haematology & Oncology
🇦🇺Frankston, Victoria, Australia
Medical University of Innsbruck
🇦🇹Innsbruck, Austria
Edegem - UNIV UZ Antwerpen
🇧🇪Edegem, Belgium
UNIV UZ Gent
🇧🇪Gent, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
INS Bergonie
🇫🇷Bordeaux, France
HOP Timone
🇫🇷Marseille, France
Charite Universitätsmedizin Berlin KöR
🇩🇪Berlin, Germany
CTR Eugène Marquis
🇫🇷Rennes, France
Universitätsklinikum Heidelberg
🇩🇪Heidelkberg, Germany
INS Gustave Roussy
🇫🇷Villejuif, France
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria Integrata Verona
🇮🇹Verona, Italy
Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Spain
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
ClÃnica Universidad de Navarra
🇪🇸Pamplona, Spain
Instituto Valenciano de OncologÃa
🇪🇸Valencia, Spain
University Hospital Bern/Inselspital Bern
🇨ðŸ‡Bern, Switzerland
University Hospital Geneva
🇨ðŸ‡Geneve, Switzerland