A Study to Test How Well Different Doses of BI 4060107 Are Tolerated by People With Advanced Cancer (Solid Tumours)
14. september 2026 oppdatert av: AIMEDBIO
A First-in-human Phase I, Open-label, Multicentre Trial of i.v. Administrations of BI 4060107 in Patients With Unresectable Advanced and/or Metastatic Solid Tumours
This study is open to adults with advanced cancer who have selected types of solid tumours that cannot be surgically removed. People can join the study if they have tried all available treatments and have no other options. The purpose of this study is to find the highest dose of a medicine called BI 4060107 that people with advanced cancer can tolerate. In this study, BI 4060107 is given to humans for the first time.
Participants are divided into different dose groups based on when they join the study. Each participant within a dose group receives the same dose, with the lowest dose given to the first group. The next group receives a higher dose if the lower dose is tolerated.
Participants can stay in the study for up to 3 years if they benefit from the treatment and can tolerate it. During this time, they visit the study site regularly. After the first treatment, participants stay overnight for 1 night at the study site. At the visits, the doctors check the health of the participants and note any health problems that could have been caused by BI 4060107.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
90
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Boehringer Ingelheim
- Telefonnummer: 18002430127
- E-post: clintriage.rdg@boehringer-ingelheim.com
Studiesteder
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Victoria
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Heidelberg, Victoria, Australia, 3048
- Austin Health
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Ta kontakt med:
- Boehringer Ingelheim
- Telefonnummer: 1800271035
- E-post: australia@bitrialsupport.com
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Texas
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Irving, Texas, Forente stater, 75039
- Texas Oncology - Irving
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Ta kontakt med:
- Boehringer Ingelheim
- Telefonnummer: 18336022368
- E-post: unitedstates@bitrialsupport.com
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Villejuif, Frankrike, 94800
- Institut Gustave Roussy
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Ta kontakt med:
- Boehringer Ingelheim
- Telefonnummer: 0805102354
- E-post: france@bitrialsupport.com
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Tokyo, Chuo-ku, Japan, 104-0045
- National Cancer Center Hospital
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Ta kontakt med:
- Boehringer Ingelheim
- Telefonnummer: 05050508862
- E-post: nippon@bitrialsupport.com
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
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Ta kontakt med:
- Boehringer Ingelheim
- Telefonnummer: 0808802084
- E-post: namhan@bitrialsupport.com
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Seoul, Sør -Korea, 06351
- Samsung Medical Center
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Ta kontakt med:
- Boehringer Ingelheim
- Telefonnummer: 0808802084
- E-post: namhan@bitrialsupport.com
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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:
- A patient must be ≥18 years of age and at least at the legal age of consent in countries where it is older than 18 years at the time of signature on the Informed Consent Forms (ICFs)
- Signed and dated written main informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Patients with histologically or cytologically confirmed diagnosis of an unresectable advanced and/or metastatic or relapsed/refractory solid tumour.
- Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. The patient must have exhausted available treatment options as per local recommendations and reimbursement policies.
- Further inclusion criteria apply
Exclusion Criteria:
- Patients who have previously received an agent with the same target as the investigational medicinal product (IMP)
- Treatment with a systemic anti-cancer therapy, an investigational device or an investigational drug within 28 days or 5 half-lives (whichever is shorter) of the first administration of trial medication
- Radiotherapy within 28 days prior to first administration of trial medication except for palliative radiotherapy to regions other than the chest, or radiotherapy for brain metastases as described under the inclusion criteria in the protocol, is allowed if completed at least 14 days prior to first administration of trial medication
- Current enrolment in another investigational device or drug trial
- 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: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Cohort 1: BI 4060107 dose level 1
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BI 4060107
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Eksperimentell: Cohort 2: BI 4060107 dose level 2
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BI 4060107
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Eksperimentell: Cohort 3: BI 4060107 dose level 3
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BI 4060107
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Eksperimentell: Cohort 4: BI 4060107 dose level 4
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BI 4060107
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Eksperimentell: Cohort 5: BI 4060107 dose level 5
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BI 4060107
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Occurrence of dose limiting toxicity(ies) DLT(s) during the primary DLT evaluation period
Tidsramme: up to 21 days
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up to 21 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Occurrence of adverse events (AEs) during the on-treatment period
Tidsramme: up to 36 months
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up to 36 months
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Occurrence of AE fulfilling DLT criteria during the on-treatment period
Tidsramme: up to 36 months
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up to 36 months
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Maximum measured concentration (Cmax) of pharmacokinetic (PK) parameters of BI 4060107
Tidsramme: up to 4 days per cycle
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(duration of a treatment cycle is 21 days; maximum treatment duration is 36 months)
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up to 4 days per cycle
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Cmax of analyte I
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Cmax of analyte II
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Cmax of analyte III
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Area under the concentration-time curve of PK parameters of BI 4060107 over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Area under the concentration-time curve of analyte I over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Area under the concentration-time curve of analyte II over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Area under the concentration-time curve of analyte III over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Area under the concentration-time curve of PK parameters of BI 4060107 over the dosing interval τ (AUCτ)
Tidsramme: up to 4 days per cycle
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up to 4 days per cycle
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Area under the concentration-time curve of analyte I over the dosing interval τ (AUCτ)
Tidsramme: up to 4 days per cycle
|
up to 4 days per cycle
|
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Area under the concentration-time curve of analyte II over the dosing interval τ (AUCτ)
Tidsramme: up to 4 days per cycle
|
up to 4 days per cycle
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Area under the concentration-time curve of analyte III over the dosing interval τ (AUCτ)
Tidsramme: up to 4 days per cycle
|
up to 4 days per cycle
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
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)
30. september 2026
Primær fullføring (Antatt)
13. mai 2030
Studiet fullført (Antatt)
13. mai 2030
Datoer for studieregistrering
Først innsendt
14. september 2026
Først innsendt som oppfylte QC-kriteriene
14. september 2026
Først lagt ut (Faktiske)
18. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
18. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2035-0001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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