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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)

Phase 1
Recruiting
Conditions
Solid Tumors
Interventions
Drug: BI 1703880
Drug: Ezabenlimab
Registration Number
NCT05471856
Lead Sponsor
Boehringer Ingelheim
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
66
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

Read More
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

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)BI 1703880-
BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)Ezabenlimab-
Primary Outcome Measures
NameTimeMethod
Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation periodup to 6 weeks
Secondary Outcome Measures
NameTimeMethod
Occurrence of DLTs during the on-treatment periodup to 804 days
Maximum measured concentration of BI 1703880 in plasma (Cmax)up to 804 days
Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)up to 804 days

Trial Locations

Locations (13)

Saitama Medical University International Medical Center

🇯🇵

Saitama, Hidaka, Japan

Hospital Vall d'Hebron-Barcelona-47683

🇪🇸

Barcelona, Spain

Instituto Valenciano de Oncología

🇪🇸

Valencia, Spain

Valkyrie Clinical Trials

🇺🇸

Los Angeles, California, United States

Yale University School of Medicine

🇺🇸

New Haven, Connecticut, United States

John Theurer Cancer Center

🇺🇸

Hackensack, New Jersey, United States

National Cancer Center Hospital East

🇯🇵

Chiba, Kashiwa, Japan

Japanese Foundation for Cancer Research

🇯🇵

Tokyo, Koto-ku, Japan

CIO Clara Campal

🇪🇸

Madrid, Spain

Hospital Clínico de Valencia

🇪🇸

Valencia, Spain

The Royal Marsden Hospital, Chelsea

🇬🇧

London, United Kingdom

Churchill Hospital

🇬🇧

Oxford, United Kingdom

The Royal Marsden Hospital, Sutton

🇬🇧

Sutton, United Kingdom

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