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A Study in People With Advanced Cancer to Test How Well Different Doses of BI 3819026 Are Tolerated When Taken Alone and Together With Ezabenlimab

3. august 2026 oppdatert av: Boehringer Ingelheim

A First-in-human Phase I, Open-label, Multicentre, Dose Escalation Trial of BI 3819026 in Combination With Ezabenlimab in Patients With Unresectable Advanced or Metastatic Solid Cancers to Determine the Maximum Tolerated Dose (MTD) and Recommended Dose for Expansion (RDE)

This study is open to adults with advanced cancer. The purpose of this study is to find the highest dose of BI 3819026 that people with advanced cancer can tolerate when taken alone and together with ezabenlimab. BI 3819026 and ezabenlimab are study medicines that may fight cancer.

Participants first receive one treatment of BI 3819026 alone, followed by treatment with a combination of BI 3819026 and ezabenlimab. Different doses of BI3819026 are given to small groups of participants, starting with the lowest dose. Treatment with the next higher dose of BI 3819026 starts only if the previous dose was tolerated. Each participant remains on the same dose of BI 3819026 throughout the study.

Participants are in the study for up to 2 years as long as they can tolerate the treatment and their condition does not get worse. During this time, they visit the study site regularly. The doctors look at the occurrence of certain health problems. They also regularly take blood samples, image participants' tumours, and take note of any unwanted effects.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

60

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Connecticut
      • New Haven, Connecticut, Forente stater, 06511
    • New Jersey
      • Hackensack, New Jersey, Forente stater, 07601
        • Har ikke rekruttert ennå
        • Hackensack University Medical Center
        • Ta kontakt med:
    • New York
      • New York, New York, Forente stater, 10016
        • Har ikke rekruttert ennå
        • New York University Langone Medical Center
        • Ta kontakt med:
    • Tennessee
      • Nashville, Tennessee, Forente stater, 37203
  • Japan
      • Chiba, Kashiwa, Japan, 277-8577
        • Rekruttering
        • National Cancer Center Hospital East
        • Ta kontakt med:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Rekruttering
        • National Cancer Center Hospital
        • Ta kontakt med:
  • Spania
      • Barcelona, Spania, 08035
        • Rekruttering
        • Hospital Universitari Vall d'Hebron
        • Ta kontakt med:
      • Pamplona, Spania, 31008
        • Rekruttering
        • Clinica Universidad de Navarra
        • Ta kontakt med:
      • Valencia, Spania, 46010
        • Rekruttering
        • Hospital Clínico Universitario de Valencia
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria :

  1. Participants with histologically confirmed unresectable advanced or metastatic solid tumours who have documented progression after or are refractory to or ineligible for established and available therapies with proven clinical benefit, or have declined such therapy.
  2. At least one measurable disease lesion outside of the central nervous system (CNS) defined per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1

  3. Patients with brain metastases are eligible provided they meet the following criteria:

    • Brain metastases have adequately been treated and are without progression or haemorrhage and are considered stable and asymptomatic by the investigator,
    • Radiotherapy and/or surgery for brain metastases was completed at least 14 and 28 days, respectively, prior to the first administration of BI 3819026,
    • Patient is off steroids and anti-convulsive drugs for at least 7 days prior to the first administration of BI 3819026 and has no requirement for such therapy at the time of initiating trial treatment.
  4. Availability of archived formalin-fixed and paraffin embedded (FFPE) tumour tissue. Patients who do not have archived FFPE tumour tissue available may be allowed to enrol without archival tumour tissue upon agreement between the investigator and the Sponsor
  5. All toxicities related to previous anti-cancer therapies have resolved to Grade ≤1 or baseline prior to trial treatment administration (except for alopecia, peripheral neuropathy and endocrinopathies considered irreversible [like hypothyroidism], and amenorrhea/menstrual disorders which can be any grade)
  6. Adequate liver, bone marrow and renal organ function Further inclusion criteria apply.

Exclusion Criteria :

  1. Previous or concomitant malignancies other than the one treated in this trial within the last 3 years except:

    • Effectively treated non-melanoma skin cancers
    • Effectively treated carcinoma in situ of the cervix
    • Effectively treated ductal carcinoma in situ of the breast
    • Other effectively treated malignancy that is considered cured by local treatment
  2. Has received prior therapy with an immune-checkpoint inhibitor that was discontinued due to immune-related adverse events (AE)
  3. Prior treatment with systemic anti-cancer drugs (including any agents or investigational medicinal products) within 3 weeks or 5 half-lives (whichever is shorter) before the first dose of trial treatment

  4. Radiotherapy within 4 weeks prior to start of the trial treatment except as follows:

    • Palliative radiotherapy to regions other than the chest is allowed if completed at least 2 weeks prior and is not on the target lesion (which should be outside of the radiation field)
    • Single dose palliative radiotherapy for symptomatic metastasis that is not the target lesion (which should be outside of the radiation field) within 2 weeks prior may be allowed
  5. Active/previous history of interstitial lung disease, pulmonary fibrosis, organising pneumonia or non-infectious pneumonitis (any grade)
  6. Patients with active autoimmune disease or a documented history of autoimmune disease, that requires systemic treatment, e.g. corticosteroids or immunosuppressive drugs, except patients with vitiligo, resolved childhood asthma/atopy, alopecia, or any chronic skin condition that does not require systemic therapy; patients with autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and/or controlled Type 1 diabetes mellitus on a stable insulin regimen are eligible
  7. Patient has a diagnosis of immunodeficiency other than human immunodeficiency virus (HIV)

  8. Patients with history of HIV infection who meet one or more of the following criteria:

    • CD4+ count <350 cells/µL
    • Viral load >400 copies/mL
    • Not receiving antiretroviral therapy
    • Receiving established antiretroviral therapy for less than four weeks prior to the start of trial treatment
    • History of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within 12 months prior to start of trial treatment Patients with a history of HIV who do not meet any of the exclusion criteria above are eligible to participate but the patient must be under the care of an HIV/Infectious Diseases specialist, or an HIV/Infectious Diseases specialist must be consulted prior to inclusion Further exclusion criteria apply.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 1
Dose escalation
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 2
Dose escalation
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 3
Dose escalation
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 4
Dose escalation
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 5
Dose escalation
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Eksperimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill
Legemiddel: BI 3819026
BI 3819026
Legemiddel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Occurrence of dose-limiting toxicities (DLTs) in the primary DLT evaluation period
Tidsramme: Up to 30 days
Up to 30 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Occurrence of adverse events (AEs) with onset during the on-treatment period
Tidsramme: Up to 2 years
Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
Tidsramme: Up to 2 years
Up to 2 years
Occurrence of AEs with onset during Cycle 1
Tidsramme: Up to 15 days
Up to 15 days
Occurrence of DLTs with onset during Cycle 1
Tidsramme: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
Tidsramme: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
Tidsramme: Up to Day 30
Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
Tidsramme: Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 1
Tidsramme: Up to 15 days
Up to 15 days
Area under concentration-time curve of BI 3819026 alone over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
Tidsramme: Up to Day 30
Up to Day 30
Area under concentration-time curve of BI 3819026 + ezabenlimab combination over a uniform dosing interval 0 - 504 h (AUC 0-504) in cycle 3
Tidsramme: Up to Day 30
Up to Day 30
Treatment-induced changes in target cells as compared with baseline
Tidsramme: At baseline and up to 2 years
Backfill cohorts only: only patients in whom sequential biopsies are technically feasible and deemed safe by the investigator will be eligible
At baseline and up to 2 years
Treatment-induced changes in target cells ratio as compared with baseline
Tidsramme: At baseline and up to 2 years
Backfill cohorts only
At baseline and up to 2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boehringer Ingelheim

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

5. juni 2028

Studiet fullført (Antatt)

15. oktober 2030

Datoer for studieregistrering

Først innsendt

18. mai 2026

Først innsendt som oppfylte QC-kriteriene

18. mai 2026

Først lagt ut (Faktiske)

26. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 2012-0001
  • 2025-522953-21-00 (Registeridentifikator: CTIS)
  • U1111-1328-0914 (Registeridentifikator: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD-delingstidsramme

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

Tilgangskriterier for IPD-deling

For study documents -upon signing of a 'Document Sharing Agreement'.For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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