Solid Tumors
Conditions
Brief summary
This study is open to adults with advanced solid tumours. People with solid tumours for whom previous treatment was not successful or no treatment exists can take part. The purpose of this study is to find the highest dose of a medicine called BI 1821736 that people with advanced solid tumours can tolerate. BI 1821736 is a type of immunotherapy. It is a special virus that kills cancer cells and helps the immune system fight cancer. In this study, BI 1821736 is given to humans for the first time. Participants receive BI 1821736 as an infusion into a vein about every 3 weeks for up to 3 months. Study doctors regularly check the participants' health and monitor the tumours. The doctors also take note of any unwanted effects that could have been caused by BI 1821736.
Interventions
DRUGBI 1821736
Solution for infusion/injection
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 confirmed diagnosis of malignant tumor. * Advanced, unresectable and/or metastatic or relapsed/refractory solid tumors. * Has failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Patient must have exhausted available treatment options known to prolong survival for their disease. * Has at least one tumoral lesion which is amenable to biopsy. * Signed and dated, written informed consent form (ICF) in accordance with ICH-GCP and local legislation obtained prior to any trial-specific procedures, sampling, or analyses that are not part of normal standard of practice care. * Eastern Cooperative Oncology Group score of 0 or 1. * Adequate organ function or bone marrow reserve defined as demonstrated at screening by the following laboratory values: * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (≥ 1.5 x 10\^3/μL)(≥ 1500/mm\^3); haemoglobin ≥ 90 g/L (≥ 9.0 g/dL)(≥ 5.6 mmol/L); platelets ≥ 100 x 10\^9/L (≥ 100 x 10\^3/μL)(≥ 100 x 10\^3/mm\^3) without the use of haematopoietic growth factors within 4 weeks of start of trial medication. * Creatinine ≤ 1.5 times the upper limit of normal (ULN). * Total bilirubin ≤ 1.5 times the ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3 times ULN or direct bilirubin ≤ 1.5 times ULN. * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 times ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN if transaminase elevation is attributable to liver metastases. * Partial thromboplastin (PT) / activated partial thromboplastin time (aPTT) \<1.5 times ULN unless on a stable dose of an anticoagulant. * All toxicities related to previous anti-cancer therapies have resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be ≤ CTCAE Grade 2 and amenorrhea/menstrual disorders which can be any grade). * Further inclusion criteria apply
Exclusion criteria
* Major surgery (major according to the investigator's assessment) performed within 4 weeks prior to start of study treatment. * Previous treatment with Vesicular Stomatitis Virus (VSV)-based agents. * Patients with brain metastases unless they have completed brain radiotherapy and are asymptomatic. * Radiotherapy within 4 weeks prior to the start of study treatment, except in case of a brief course of palliative radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture) which can then be completed within two weeks prior to start of study treatment. Note: No radiation must have been given to any lesions planned to be biopsied within 6 months of start of treatment. * Prior (within 3 weeks of first dose) or concomitant use of systemic corticosteroids (\>10 mg daily prednisone or equivalent). * Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of a medication or a condition considered a high risk for complications from biopsy as per the Investigator's judgement. * Prior (within 3 weeks of first dose or less than 5 half-lives) or concomitant use of interferon, immunotherapy agents, or tamoxifen. * Active infection requiring systemic therapy (antibacterial, antiviral, antiparasitic or antifungal therapy) at the start of treatment in the trial. * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of DLTs in the MTD Evaluation Period | First treatment cycle, i.e., 21 days. | Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period is reported as count of participants with DLTs in the MTD evaluation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of DLTs During the On-treatment Period | From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days. | Occurrence of DLTs during the on-treatment period is reported as count of participants with DLTs during the on-treatment period. |
| Occurrence of AEs During the On-treatment Period | From first study drug administration until end of study drug administration + 15 days of residual effect period (REP), up to 80 days. | Occurrence of adverse events (AEs) during the on-treatment period is reported as count of participants with AEs during the on-treatment period. |
Countries
Canada, Spain, Sweden, United States
Participant flow
Recruitment details
This was an open-label, Phase I dose escalation and expansion trial to investigate safety and efficacy of BI 1821736 in patients with advanced solid tumors.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 18 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 4 / 8 |
| other Total, other adverse events | 2 / 2 | 8 / 8 |
| serious Total, serious adverse events | 1 / 2 | 6 / 8 |
Outcome results
None listed