Testing how well different doses of BI 4060107 are tolerated in adults with unresectable advanced solid tumours

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, interventional study enrolling adults with unresectable or metastatic solid tumours who have exhausted standard treatments. Participants are assigned to sequential dose groups to identify the highest tolerable dose of BI 4060107, administered for up to three years if beneficial. The study includes inpatient observation after the initial dose and regular follow-up visits to monitor safety and health status. Enrollment relies on informed consent and local eligibility criteria, with ongoing assessment of tolerability at each dose level. Boehringer Ingelheim collaborates with AIMEDBIO, and sites include centers in the United States and France.

Why it matters

Who can join: the full rules

Inclusion criteria:

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

Where it's running

• Institut Gustave Roussy
  Villejuif, France Recruiting
• National Cancer Center Hospital
  Tokyo, Chuo-ku, Japan Recruiting
• Samsung Medical Center
  Seoul, South Korea Recruiting
• Texas Oncology - Irving
  Irving, Texas, United States Not yet recruiting
• Austin Health
  Heidelberg, Victoria, Australia Not yet recruiting
• Seoul National University Hospital
  Seoul, South Korea Not yet recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 18002430127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.