ClinicaliQ Trial Snapshot
- A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours) — Recruiting • Phase I • Oncology • NCT05471856.
- What is being tested: Different dose combinations of BI 1703880 (an experimental medicine) with ezabenlimab (an existing immunotherapy) to determine tolerability and the maximum tolerated dose in patients with advanced solid tumours.
- Patient eligibility overview: Adults with advanced solid tumours who have either failed previous treatments or have no standard treatment options available; this represents a treatment-resistant population with limited alternatives.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This study is open to adults with different types of advanced cancer. People can take part if previous treatment was not successful, or no treatment exists. The purpose of this study is to find the highest dose of a medicine called BI 1703880 that people with advanced cancer can tolerate when taken together with ezabenlimab. BI 1703880 and ezabenlimab are medicines that may help the immune system fight cancer. In this study, BI 1703880 is given to people for the first time. Participants get BI 1703880 and ezabenlimab as infusions…
Eligibility Snapshot
- : * Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)). * Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options. * Has a lesion amenable to pre-treatment and on-treatment biopsy and patient consents to both biopsies. * Medically fit and willing to undergo all mandatory trial procedures. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. * Adequate organ function or bone marrow reserve as demonstrated at screening by the following laboratory values: * Absolute neutrophil count ≥ 1.5x10^9/L (≥ 1.5x10^3/μL, ≥ 1500/mm3); platelet count ≥ 100x10^9/L (≥ 100x10^3/μL, ≥ 100x10^3/mm3), without the use of hematopoietic growth factors within 4 weeks of start of trial medication * Haemoglobin ≥ 90 g/L (≥ 9.0 g/dL, ≥ 5.6 mmol/L) * Estimated glomerular filtration rate (eGFR) ≥60 ml/min/1.73m^2 (as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula) * Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3 x ULN if no demonstrable liver metastases, or otherwise ≤ 5 x ULN…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.