Different doses of BI 3810944 for adults with advanced solid tumors

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 dose‑finding trial enrolling adults with advanced solid tumours whose prior treatments have failed or for whom no standard effective therapy exists. Participants receive BI 3810944 on a schedule that starts with a short period of weekly dosing and then usually moves to dosing every three weeks, with treatment allowed for up to two years if there is benefit. The study uses dose escalation to identify tolerable and recommended doses and closely monitors safety with lab tests, regular clinical visits, and imaging to measure tumour size. Early visits include overnight hospital stays and participants are followed regularly for side effects and tumour response.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Trial participant population specifically to Part A and B:

   * Part A only: participants with any histologically or cytologically confirmed diagnosis of solid tumour who failed conventional treatment or for whom no therapy of proven efficacy exists or who is not eligible for established treatment options. Participant must have exhausted available treatment options known to prolong survival for their disease.
   * Part B only: participants with histologically or cytologically confirmed diagnosis of who has progressed on, or is intolerant to available standard therapies, or for whom no standard therapy with proven benefit exists according to the local and institutional guidelines. Participants should not have received \>3 previous lines of treatment (excluding prior systemic regimens received at adjuvant or neoadjuvant setting and excluding treatment with tumour-infiltrating lymphocytes at any timepoint). B-raf protein kinase (BRAF) mutation status must be known prior to screening
2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1
3. Presence of at least one measurable lesion outside of central nervous system (CNS) as defined per response evaluation criteria in solid tumours (RECIST v 1.1)
4. Age ≥18 years
5. Adequate organ function
6. Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator
7. All toxicities related to previous anticancer therapies have resolved to common terminology criteria for adverse events (CTCAE) Grade ≤1 prior to trial treatment administration (except for alopecia and peripheral neuropathy which must be CTCAE Grade ≤2 and amenorrhea/menstrual disorders which can be any Grade) Further inclusion criteria apply.

Exclusion Criteria:

1. Active primary central nervous system (CNS) malignancy, active untreated CNS metastases and/or carcinomatous meningitis

   * Participants with asymptomatic (i.e. no clinical neurological symptoms) brain lesions are eligible provided they meet the following criteria:

     * Radiotherapy or surgery for brain metastases was completed ≥2 weeks before the first administration of BI 3810944
     * Patient is off steroids for ≥7 days (physiologic doses of steroids are permitted), and the patient is off anti-epileptic drugs for ≥7 days or on stable doses of anti-epileptic drugs for malignant CNS disease
2. A diagnosis of immunodeficiency; receiving chronic systemic therapy exceeding prednisone 10 mg daily or equivalent or any other form of immunosuppressive therapy within 7 days before the step-up dose of BI 3810944
3. Prior anticancer therapy:

   * Participants who have been treated with any other anticancer drug(s), within 28 days or within 5 half-life periods (whichever is shorter) prior to the first administration of BI 3810944
   * Participants who have been treated with extensive field radiotherapy including whole brain irradiation, within 2 weeks prior to first administration of BI 3810944
4. Prior treatment with organ transplant or allogenic hematopoietic stem-cell transplant
5. Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)
6. Women who are pregnant, breastfeeding or who plan to become pregnant or breastfeeding during the trial or within 4 months after the last dose of BI 3810944 Further exclusion criteria apply.

Where it's running

• University of Louisville
  Louisville, Kentucky, United States Recruiting
• Tennessee Oncology, PLLC - Elliston Place Plaza DDU
  Nashville, Tennessee, United States Recruiting
• Cliniques Universitaires Saint-Luc
  Brussels, Belgium Recruiting
• UZ Leuven
  Leuven, Belgium Recruiting
• Radboud Universitair Medisch Centrum
  Nijmegen, Netherlands 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: 1-800-243-0127

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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.