Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1
Boehringer Ingelheim (Voir sur ClinicalTrials)
mars 2022
octobre 2028
06 août 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | St�phane CHAMPIAT | 26/02/2024 14:14:26 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CTR Eugène Marquis - 35042 - Rennes - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| HOP Timone - 13385 - Marseille - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
| INS Bergonie - 33000 - Bordeaux - France | Boehringer Ingelheim | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.