New drug combo aims to boost immune system against advanced cancers

NCT ID NCT05471856

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    13 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • CIO Clara Campal

    RECRUITING

    Madrid, 28050, Spain

  • Churchill Hospital

    RECRUITING

    Oxford, OX3 7LE, United Kingdom

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Instituto Valenciano de Oncología

    RECRUITING

    Valencia, 46009, Spain

  • Japanese Foundation for Cancer Research

    RECRUITING

    Tokyo, Koto-ku, 135-8550, Japan

  • John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • National Cancer Center Hospital East

    RECRUITING

    Chiba, Kashiwa, 277-8577, Japan

  • Saitama Medical University International Medical Center

    RECRUITING

    Saitama, Hidaka, 350-1298, Japan

  • The Royal Marsden Hospital, Chelsea

    RECRUITING

    London, SW3 6JJ, United Kingdom

  • The Royal Marsden Hospital, Sutton

    RECRUITING

    Sutton, SM2 5PT, United Kingdom

  • Valkyrie Clinical Trials

    RECRUITING

    Los Angeles, California, 90067, United States

  • Yale University School of Medicine

    RECRUITING

    New Haven, Connecticut, 06511, United States

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