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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 augusti 2026 uppdaterad 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

60

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Connecticut
      • New Haven, Connecticut, Förenta staterna, 06511
    • New Jersey
      • Hackensack, New Jersey, Förenta staterna, 07601
        • Har inte rekryterat ännu
        • Hackensack University Medical Center
        • Kontakt:
    • New York
      • New York, New York, Förenta staterna, 10016
        • Har inte rekryterat ännu
        • New York University Langone Medical Center
        • Kontakt:
    • Tennessee
      • Nashville, Tennessee, Förenta staterna, 37203
  • Japan
      • Chiba, Kashiwa, Japan, 277-8577
        • Rekrytering
        • National Cancer Center Hospital East
        • Kontakt:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • Rekrytering
        • National Cancer Center Hospital
        • Kontakt:
  • Spanien
      • Barcelona, Spanien, 08035
        • Rekrytering
        • Hospital Universitari Vall d'Hebron
        • Kontakt:
      • Pamplona, Spanien, 31008
        • Rekrytering
        • Clinica Universidad de Navarra
        • Kontakt:
      • Valencia, Spanien, 46010
        • Rekrytering
        • Hospital Clínico Universitario de Valencia
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 1
Dose escalation
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 2
Dose escalation
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 3
Dose escalation
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 4
Dose escalation
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 5
Dose escalation
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 3 backfill
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 4 backfill
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)
Experimentell: BI 3819026 + Ezabenlimab (BI 754091) dose group 5 backfill
Läkemedel: BI 3819026
BI 3819026
Läkemedel: Ezabenlimab (BI 754091)
Ezabenlimab (BI 754091)

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Occurrence of adverse events (AEs) with onset during the on-treatment period
Tidsram: Up to 2 years
Up to 2 years
Occurrence of DLTs with onset during the on-treatment period
Tidsram: Up to 2 years
Up to 2 years
Occurrence of AEs with onset during Cycle 1
Tidsram: Up to 15 days
Up to 15 days
Occurrence of DLTs with onset during Cycle 1
Tidsram: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 1
Tidsram: Up to 15 days
Up to 15 days
Maximum measured concentration of BI 3819026 alone (C max) in cycle 3
Tidsram: Up to Day 30
Up to Day 30
Maximum measured concentration of BI 3819026 + ezabenlimab combination (C max) in cycle 3
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: Up to Day 30
Up to Day 30
Treatment-induced changes in target cells as compared with baseline
Tidsram: 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
Tidsram: At baseline and up to 2 years
Backfill cohorts only
At baseline and up to 2 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Boehringer Ingelheim

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2026

Primärt slutförande (Beräknad)

5 juni 2028

Avslutad studie (Beräknad)

15 oktober 2030

Studieregistreringsdatum

Först inskickad

18 maj 2026

Först inskickad som uppfyllde QC-kriterierna

18 maj 2026

Första postat (Faktisk)

26 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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