Different doses of BI 3810944 for adults with advanced solid tumors

A First-in-human, Phase I, Open-label, Non-randomized, Multicentre Dose Escalation and Expansion Trial of BI 3810944 in Patients With Solid Tumours and Melanoma

This trial tests different doses of the experimental drug BI 3810944 to see if adults with advanced solid tumours, including melanoma, who have not had success with standard treatments can tolerate it and might benefit.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 6 sites (Louisville, Kentucky and 5 other locations)
• Trial ID: NCT07224425 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed advanced solid tumours (including melanoma) who have failed or are not eligible for standard treatments—and for Part B, those who progressed on or were intolerant to available therapies with known BRAF status and generally no more than three prior systemic lines—are the intended candidates.

Not a fit: Patients with early-stage disease who have effective standard treatment options, or those who cannot travel to the study sites or meet safety/laboratory criteria, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, BI 3810944 could provide a new treatment option that shrinks or slows growth of advanced solid tumours for patients who have exhausted standard therapies.

How similar studies have performed: Dose‑escalation Phase 1 trials of new oncology agents commonly identify safe dose ranges and occasionally show early anti‑tumour activity, but BI 3810944 itself is investigational with limited published outcome data to date.

Eligibility criteria

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 first 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 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 this trial is running

Louisville, Kentucky and 5 other locations

• University of Louisville — Louisville, Kentucky, United States (Not_yet_recruiting)
• Tennessee Oncology, PLLC - Elliston Place Plaza DDU — Nashville, Tennessee, United States (Recruiting)
• University of Virginia Health System — Charlottesville, Virginia, United States (Not_yet_recruiting)
• Cliniques Universitaires Saint-Luc — Brussels, Belgium (Not_yet_recruiting)
• UZ Leuven — Leuven, Belgium (Not_yet_recruiting)
• Radboud Universitair Medisch Centrum — Nijmegen, Netherlands (Not_yet_recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Solid Tumours; Melanoma