Solid Tumors
Conditions
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.
Interventions
DRUGBI 1831169
BI 1831169
anti-PD-1 antibody
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, Austria, Belgium, Canada, France, Germany, Italy, Spain, Switzerland, United States
Contacts
CONTACTBoehringer Ingelheim
Outcome results
None listed