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NCT05471856

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
PHASE1Ages 18+InterventionalTreatment
Boehringer Ingelheim
~66 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:BI 1703880Ezabenlimab

At a glance

Recruiting sites
13 of 13 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period
Measured over up to 6 weeks

Conditions

Solid Tumors

Explore related trials

Solid Neoplasm

NCT05471856

Where you'd take part

This study runs at 13 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Churchill Hospital

    Oxford, United Kingdomstudy coordinator listed

    Recruiting

  • CIO Clara Campal

    Madrid, Spainstudy coordinator listed

    Recruiting

  • Hospital Clinico Universitario de Valencia

    Valencia, Spainstudy coordinator listed

    Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spainstudy coordinator listed

    Recruiting

  • Instituto Valenciano de Oncología

    Valencia, Spainstudy coordinator listed

    Recruiting

  • Japanese Foundation for Cancer Research

    Tokyo, Koto-ku, Japanstudy coordinator listed

    Recruiting

  • John Theurer Cancer Center

    Hackensack, New Jerseystudy coordinator listed

    Recruiting

  • National Cancer Center Hospital East

    Chiba, Kashiwa, Japanstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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 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 part of normal standard of practice care. Note: If a patient declines to participate in the voluntary biobanking component of the trial, he/she will not be excluded from other aspects of the trial.

Exclusion

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.

What this trial measures

  • Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation periodup to 6 weeks