Testing different doses of BI 3968621 alone or with ezabenlimab in adults with advanced cancer

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/early dose-finding study in adults with advanced, unresectable or metastatic solid tumors. Participants receive BI 3968621 alone or in combination with ezabenlimab, across Part A, Part A2, and Part B to establish tolerability and identify a suitable dose, with Part A2 focusing on kidney cancer. The trial will monitor safety, tolerability, and preliminary anti-tumor activity, including tumor growth suppression or shrinkage. Brain metastases are allowed if patients meet protocol criteria, and eligibility requires measurable disease, good performance status, and adequate organ function. Study sites are in Florida, Georgia, and Pennsylvania, led by Boehringer Ingelheim.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female participants ≥18 years of age and at least at the legal age of consent
* Patients with a histologically confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type). Patients who have failed conventional treatment or for whom no therapy of proven efficacy exists or who are not eligible for established treatment options. Patients must have exhausted approved treatment options known to prolong survival for their disease
* At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy ≥3 months at the start of treatment in the opinion of the investigator
* Patients with known brain metastases are eligible, provided they meet the protocol-defined criteria
* Patients must have adequate organ function based on haematological, hepatic, renal, and coagulation parameters Further inclusion criteria apply.

Exclusion Criteria:

* Previous or concomitant malignancies other than the one treated in this trial within the past 3 years (except effectively treated malignancy considered cured by local treatment, e.g. non melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ)
* Patient with known leptomeningeal disease or spinal cord compression due to disease
* Patients with hepatitis C infection or active hepatitis B infection (chronic or acute)
* Patients with known history of Human immunodeficiency virus (HIV) infection who meet protocol-defined criteria
* Patient with active autoimmune disease or a documented history of autoimmune disease, which requires systemic treatment (e.g. corticosteroids or immunosuppressive drugs)
* Patient with a diagnosis of immunodeficiency other than HIV
* Manifestation of malabsorption or any other condition that could affect oral absorption, distribution or metabolism of the study drug Further exclusion criteria apply.

Where it's running

• Florida Cancer Specialists-Sarasota-61670
  Sarasota, Florida, United States Recruiting
• Sarah Cannon Research Institute-Nashville-48456
  Nashville, Tennessee, United States Recruiting
• Japanese Foundation for Cancer Research
  Tokyo, Koto-ku, Japan Recruiting
• Emory University
  Atlanta, Georgia, United States Not yet recruiting
• Thomas Jefferson University
  Philadelphia, Pennsylvania, United States Not yet recruiting
• The University of Texas MD Anderson Cancer Center
  Houston, Texas, United States Not yet recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 018002430127

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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.