Actively Recruiting
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)
Led by Boehringer Ingelheim · Updated on 2025-12-17
66
Participants Needed
13
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 into a vein. During the first 6 weeks, they get BI 1703880 once a week. Later, they get BI 1703880 every 3 weeks. After the first 3 weeks, they get ezabenlimab in addition every 3 weeks. Participants can get BI 1703880 for up to 1 year and ezabenlimab for up to 2 years as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. At these visits, the doctors check participants' health and take note of any unwanted effects.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Advanced, unresectable, metastatic, relapsed, or refractory solid tumor confirmed by biopsy
- At least one measurable tumor lesion according to RECIST 1.1 criteria
- Exhausted or refused standard treatment options, or not eligible for them
- Lesion suitable for pre-treatment and on-treatment biopsy, with consent for both
- Medically fit and willing to undergo all required trial procedures
- ECOG performance status score of 0 or 1
- Adequate organ function and bone marrow reserve as shown by laboratory tests at screening:
- Absolute neutrophil count ≥ 1.5 x 10^9/L
- Platelet count ≥ 100 x 10^9/L without growth factors in prior 4 weeks
- Hemoglobin ≥ 90 g/L
- Estimated glomerular filtration rate ≥ 60 ml/min/1.73m²
- AST and ALT ≤ 3 x upper limit of normal if no liver metastases, or ≤ 5 x if due to liver metastases
- Total bilirubin ≤ 1.5 x upper limit of normal (or ≤ 3.0 x if Gilbert's syndrome)
- Partial thromboplastin time (PTT)/activated PTT < 1.5 x upper limit of normal
- Signed informed consent form according to regulations
You will not qualify if you...
- Received investigational or anti-tumor treatment within 4 weeks or 5 half-lives before starting study
- Previous treatment with STING agonist therapy
- Previous intolerance to anti-PD-1 or anti-PD-L1 therapy
- History of allergy or hypersensitivity to components of study drugs
- Use of immunosuppressive therapies exceeding 10 mg/day prednisone or equivalent, or TNF-alpha blockers
- Ongoing toxicity from previous treatments not resolved to Grade ≤1, except alopecia, dry mouth, or immunotherapy-related endocrinopathies
- Active autoimmune disease not related to treatment, except certain endocrinopathies
- History or complications of pneumonitis or interstitial lung disease within last 12 months, or pneumonitis from immunotherapy
AI-Screening
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Trial Site Locations
Total: 13 locations
1
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06511
Actively Recruiting
3
John Theurer Cancer Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
National Cancer Center Hospital East
Chiba, Kashiwa, Japan, 277-8577
Actively Recruiting
5
Saitama Medical University International Medical Center
Saitama, Hidaka, Japan, 350-1298
Not Yet Recruiting
6
Japanese Foundation for Cancer Research
Tokyo, Koto-ku, Japan, 135-8550
Actively Recruiting
7
Hospital Universitari Vall D Hebron
Barcelona, Spain, 08035
Actively Recruiting
8
CIO Clara Campal
Madrid, Spain, 28050
Actively Recruiting
9
Instituto Valenciano de Oncología
Valencia, Spain, 46009
Actively Recruiting
10
Hospital Clinico Universitario De Valencia
Valencia, Spain, 46010
Actively Recruiting
11
The Royal Marsden Hospital, Chelsea
London, United Kingdom, SW3 6JJ
Actively Recruiting
12
Churchill Hospital
Oxford, United Kingdom, OX3 7LE
Actively Recruiting
13
The Royal Marsden Hospital, Sutton
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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