New drug combo aims to boost immune system against advanced cancers
NCT ID NCT05471856
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 4 times
Summary
This study tests a new drug, BI 1703880, combined with ezabenlimab in adults with advanced solid tumors that haven't responded to other treatments. The main goal is to find a safe dose of BI 1703880. Participants receive both drugs as infusions, with BI 1703880 given weekly then every 3 weeks, and ezabenlimab every 3 weeks. The study focuses on safety and how the body processes the drugs, not on curing the cancer.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2023
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
13 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CIO Clara Campal
RECRUITINGMadrid, 28050, Spain
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Churchill Hospital
RECRUITINGOxford, OX3 7LE, United Kingdom
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Hospital Clinico Universitario de Valencia
RECRUITINGValencia, 46010, Spain
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Hospital Universitari Vall d'Hebron
RECRUITINGBarcelona, 08035, Spain
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Instituto Valenciano de Oncología
RECRUITINGValencia, 46009, Spain
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Japanese Foundation for Cancer Research
RECRUITINGTokyo, Koto-ku, 135-8550, Japan
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John Theurer Cancer Center
RECRUITINGHackensack, New Jersey, 07601, United States
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National Cancer Center Hospital East
RECRUITINGChiba, Kashiwa, 277-8577, Japan
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Saitama Medical University International Medical Center
RECRUITINGSaitama, Hidaka, 350-1298, Japan
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The Royal Marsden Hospital, Chelsea
RECRUITINGLondon, SW3 6JJ, United Kingdom
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The Royal Marsden Hospital, Sutton
RECRUITINGSutton, SM2 5PT, United Kingdom
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Valkyrie Clinical Trials
RECRUITINGLos Angeles, California, 90067, United States
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Yale University School of Medicine
RECRUITINGNew Haven, Connecticut, 06511, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A multicenter, Dose-Escalation and expansion phase I/IIa clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, immunogenicity, and preliminary efficacy of SGT003 in patients with advanced solid tumors
- Can a radioactive 'Smart Bomb' target tough tumors?
- Can a new drug shrink advanced solid tumors?
- Can a new pill shrink advanced solid tumors?
- Can a daily pill target hard-to-treat cancers with EGFR or HER2 mutations?
- Can a Tumor-Directed injection shrink Hard-to-Treat cancers?