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Looking for participantsPhase1

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)

Sponsor: Boehringer Ingelheim

NCT ID: NCT05471856

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
BI 1703880 (drug), Ezabenlimab (drug)
How long the study runs
Study runs about 71 months (dates as stated)
About the drug or intervention
BI 1703880 — drug: BI 1703880 · Ezabenlimab — drug: Ezabenlimab
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
66
Started
2023-02-24
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for solid tumors
  • • Phase1 - 66 participants
  • • This study is open to adults with different types of advanced cancer

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with solid tumors

Where?

  • • London - The Royal Marsden Hospital, Chelsea
  • • Oxford - Churchill Hospital
  • • Sutton - The Royal Marsden Hospital, Sutton

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Solid Tumors

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

eGFRPD-L1

Treatment history

Treatments you must have had:

  • ✓ at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1

What the study is looking for

  • ✓Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible...
  • ✓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.
  • ✓activity scale (ECOG) performance status score of 0 or 1.
  • ✓healthy organ or bone marrow health as demonstrated at screening by the following laboratory values:

Who cannot take part

  • ✗Any investigational or antitumour treatment within 4 weeks or 5 half-life periods prior to the first treatment...
  • ✗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)...
  • ✗History of allergy or hypersensitivity to study agent components.
  • ✗Immunosuppressive therapies including, but not limited to, systemic corticosteroids at doses exceeding \>10 mg/day...
See the full criteria
Inclusion 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 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. Further inclusion criteria apply Exclusion Criteria: * 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

Where Is This Study? (3 UK sites)

The Royal Marsden Hospital, Chelsea

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Recruiting
Site contact (verified)

The Royal Marsden Hospital, Sutton

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Boehringer Ingelheim

Sponsor contact

CONTACT

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09