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A Study to Test Obrixtamig Treatment in People With Different Types of Advanced Cancer Who Took Part in a Previous Study With Obrixtamig

5. november 2026 oppdatert av: Boehringer Ingelheim

A Single-arm, Open-label, Safety Rollover Trial of Obrixtamig in Patients With Different Tumours

This study is open to adults with advanced cancer who received obrixtamig (BI 764532) in one of several previous studies and benefited from treatment. The goal of this study is to find out how well participants who received obrixtamig in a previous study tolerate obrixtamig. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer.

Participants in this study continue receiving obrixtamig and any other study or standard of care anti-cancer medicines they received in their previous study at the same doses and following the same treatment schedule. Treatments are given in 3-week cycles as infusions into a vein.

Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit the study site regularly. During the visits, study doctors check participants' health and take note of any unwanted effects.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

68

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiekontakt

Studiesteder

  • Belgia
      • Ghent, Belgia, 9000
  • Frankrike
      • Bordeaux, Frankrike, 33000
      • Bron, Frankrike, 69677
      • Paris, Frankrike, 75005
      • Strasbourg, Frankrike, 67091
      • Villejuif, Frankrike, 94805
  • Japan
      • Saitama, Hidaka, Japan, 350-1298
        • Saitama Medical University International Medical Center
        • Ta kontakt med:
      • Tokyo, Chuo-ku, Japan, 104-0045
        • National Cancer Center Hospital
        • Ta kontakt med:
  • Polen
      • Gdansk, Polen, 80-214
        • Medical University Gdansk
        • Ta kontakt med:
      • Lodz, Polen, 93338
        • Polish Mother's Memorial Hospital - Research Institute
        • Ta kontakt med:
  • Spania
      • Madrid, Spania, 28040
      • Madrid, Spania, 28034
        • Hospital Universitario Ramon Y Cajal
        • Ta kontakt med:
  • Tyskland
      • Dresden, Tyskland, 01307
      • Frankfurt, Tyskland, 60590
      • Würzburg, Tyskland, 97078

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion criteria :

  1. Patient is ongoing on obrixtamig treatment in any trial sponsored by Boehringer Ingelheim (hereafter referred to as the 'parent trial') that has achieved data cut-off for final analysis.
  2. Patient is benefiting from obrixtamig treatment according to investigators' assessment in the parent trial. Patients who experienced progressive disease in the parent trial will be eligible for the rollover trial, if treatment beyond progression has been agreed between the sponsor and investigators in the parent trial provided that patient is considered to derive clinical benefit.
  3. Patient meets the criteria for further obrixtamig treatment as defined in the clinical trial protocol of the parent trial they are currently participating in. Patients with ongoing dose delays due to adverse events in the parent trial are eligible, provided recovery from the adverse event takes place within the allowed time window in the parent trial.
  4. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF).
  5. Further inclusion criteria apply.

Exclusion criteria :

  1. Any medical condition which in the opinion of the investigator should exclude the patient from receiving treatment with obrixtamig.
  2. Participants who must receive or intend to receive restricted medications or any drug considered likely to interfere with the safe conduct of the trial.
  3. Women who are pregnant, nursing, or who plan to become pregnant while participating in the trial.
  4. Patients who are institutionalized due to regulatory or juridical order; or dependent on sponsor, site or investigator.
  5. 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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Rollover arm

Patients who have previously received treatment with obrixtamig in another Boehringer Ingelheim-sponsored clinical trial (referred to as the 'parent trial') will be enrolled in this rollover study.

Treatment schedule and doses in the parent study will be continued in the rollover study.
Biologisk: Obrixtamig

Obrixtamig

Andre navn:
  • BI 764532
Biologisk: Ezabenlimab

Ezabenlimab

Biologisk: Atezolizumab

Atezolizumab

Andre navn:
  • Tecentriq
Legemiddel: Topotecan

Topotecan

Biologisk: Tocilizumab

Tocilizumab

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Occurrence of treatment-emergent adverse events ( AEs) during the on-treatment period.
Tidsramme: Up to 36 months
Up to 36 months

Sekundære resultatmål

Resultatmål
Tidsramme
Obrixtamig treatment duration from the first administration in parent trial until the last administration in rollover trial.
Tidsramme: Up to 36 months
Up to 36 months

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 (Antatt)

4. mars 2027

Primær fullføring (Antatt)

3. juli 2028

Studiet fullført (Antatt)

3. juli 2028

Datoer for studieregistrering

Først innsendt

5. november 2026

Først innsendt som oppfylte QC-kriteriene

5. november 2026

Først lagt ut (Faktiske)

10. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 1438-0038
  • 2026-527407-19-00 (Registeridentifikator: CTIS (EU))
  • U1111-1342-6504 (Registeridentifikator: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

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.

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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