Clinical trial NCT05155332: 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)
Official title: Phase I Open-label, Dose Escalation Trial of BI 1831169 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumors
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Part 1.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the mono Maximum tolerated dose (MTD) evaluation period
timeFrame: up to 21 days
measure: 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)
timeFrame: up to 49 months
measure: Part 2.1, Dose escalation/Confirmation: Occurrence of Dose limiting toxicities (DLTs) during the combination Maximum tolerated dose (MTD) evaluation period
timeFrame: up to 21 days
measure: 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)
timeFrame: up to 49 months
measure: 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)
timeFrame: up to 49 months
Secondary outcomes:
measure: Part 1.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period
timeFrame: up to 49 months
measure: Part 1.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period
timeFrame: up to 49 months
measure: Part 1.2, Dose expansion: Occurrence of adverse events during the on-treatment period
timeFrame: up to 49 months
measure: Part 1.2, Dose expansion: Occurrence of DLTs during the mono MTD evaluation period
timeFrame: up to 49 months
measure: Part 2.1, Dose escalation/Confirmation: Occurrence of DLTs during the on-treatment period
timeFrame: up to 49 months
measure: Part 2.1, Dose escalation/Confirmation: Occurrence of adverse events during the on-treatment period
timeFrame: up to 49 months
measure: Part 2.2 - Dose Expansion by Indication, All Arms: Occurrence of adverse events during the on-treatment period
timeFrame: up to 49 months
measure: Part 2.2 - Dose Expansion by Indication, Arm D: Duration of objective response (DoR)
timeFrame: up to 49 months
measure: Part 2.2, Dose Expansion by Indication, Arm D: Disease control (DC)
timeFrame: up to 49 months
measure: Part 2.2, Dose Expansion by Indication, Arms E, F, G: Duration of objective response (DoR)
timeFrame: up to 49 months
measure: Part 2.2, Dose Expansion by Indication, Arms E, F, G: Disease control (DC)
timeFrame: up to 49 months
measure: Part 2.2, Dose Expansion by Indication, Arm E: Progression-Free Survival (PFS) rate at 4 months
timeFrame: up to 4 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson Cancer Center-Gilbert-55251
state: Arizona
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: Santa Monica
country: United States
facility: Providence St. John's Health Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Minneapolis
country: United States
facility: M Health Fairview University of Minnesota Medical Center
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Winston-Salem
country: United States
facility: Atrium Health Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
city: Bedford Park
country: Australia
facility: Southern Oncology Clinical Research Unit
state: South Australia
city: Frankston
country: Australia
facility: Peninsula Haematology & Oncology
state: Victoria
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Salzburg
country: Austria
facility: Salzburg Cancer Research Institute
city: Edegem
country: Belgium
facility: Edegem - UNIV UZ Antwerpen
city: Gent
country: Belgium
facility: UNIV UZ Gent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Bordeaux
country: France
facility: INS Bergonie
city: Marseille
country: France
facility: HOP Timone
city: Rennes
country: France
facility: CTR Eugène Marquis
city: Villejuif
country: France
facility: INS Gustave Roussy
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin KöR
city: Heidelkberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona
city: Barcelona
country: Spain
facility: Hospital Quiron. I.C.U.
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
city: Valencia
country: Spain
facility: Instituto Valenciano de Oncología
city: Bern
country: Switzerland
facility: University Hospital Bern/Inselspital Bern
city: Geneve
country: Switzerland
facility: University Hospital Geneva
Study officials:
References:
citation: Porosnicu M, Quinson AM, Crossley K, Luecke S, Lauer UM. Phase I study of VSV-GP (BI 1831169) as monotherapy or combined with ezabenlimab in advanced and refractory solid tumors. Future Oncol. 2022 Aug;18(24):2627-2638. doi: 10.2217/fon-2022-0439. Epub 2022 Jun 14.