Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1
AIMEDBIO (Voir sur ClinicalTrials)
octobre 2026
mai 2030
12 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Christophe MASSARD | 12/10/2026 14:15:06 | Contacter | ||
Critères
Tous
1. 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)
2. 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
3. Patients with histologically or cytologically confirmed diagnosis of an unresectable
advanced and/or metastatic or relapsed/refractory solid tumour.
4. 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.
5. Further inclusion criteria apply
Exclusion Criteria:
1. Patients who have previously received an agent with the same target as the
investigational medicinal product (IMP)
2. 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
3. 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
4. Current enrolment in another investigational device or drug trial
5. Further exclusion criteria apply