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New treatment option for Solid Tumors
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)
ClinicalTrials.gov ID: NCT05471856
What this study is testing
What is BI 1703880?
BI 1703880 is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 2 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must...
- 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.
You likely can't join if
- Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
- Prior STING agonist therapy.
- Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
- History of allergy or hypersensitivity to study agent components.
- Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding \>10 mg/day of prednisone or equivalent, and...
- Persistent toxicity from previous treatments (including immune related Adverse Events (irAEs)) that has not resolved to Grade ≤1, except for...
See the full eligibility criteria
- 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...
- 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...
- 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 if transaminase elevation is attributable to liver metastases.
- Total bilirubin ≤ 1.5 x ULN, except for patients with Gilbert's syndrome: total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
- partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT) \<1.5 x ULN
- Patients ≥18 years of age or over the legal age of consent in countries where that is greater than 18 years at the time of signature of the informed consent form (ICF).
- Signed and dated written ICF in accordance with International Council for Harmonisation- Good Clinical Practice (ICH-GCP) and local legislation, obtained before performing any protocol related procedures that are not...
- Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment whichever is shorter.
- Prior STING agonist therapy.
- Prior intolerability of a anti-programmed cell death protein 1 (PD-1) or anti-programmed cell death ligand 1 (PD-L1) therapy.
- History of allergy or hypersensitivity to study agent components.
- Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding \>10 mg/day of prednisone or equivalent, and tumour necrosis factor-alpha blockers.
- Persistent toxicity from previous treatments (including immune related Adverse Events (irAEs)) that has not resolved to Grade ≤1, except for alopecia, xerostomia, and immunotherapy related endocrinopathies.
- Evidence of active, non-treatment related autoimmune disease, except for endocrinopathies.
- History or complication of pneumonitis or interstitial lung disease within the last 12 months, or any prior pneumonitis related to immunotherapy. Further exclusion criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Hackensack, New Jersey, United States
- Chiba, Kashiwa, Japan
- Saitama, Hidaka, Japan
- Tokyo, Koto-ku, Japan
- Barcelona, Spain
- Madrid, Spain
- Valencia, Spain
- London, United Kingdom
- Oxford, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; New Haven, Connecticut, United States; Hackensack, New Jersey, United States; Chiba, Kashiwa, Japan; Saitama, Hidaka, Japan; Tokyo, Koto-ku, Japan and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.