A Study in People With Advanced Cancer (Solid Tumours) to Test Different Doses of BI 3810944 and to Find Out Whether it Helps

NCT07224425 | Recruiting Phase 1 FDA Drug

• 3 other identifiers: 1527-00012025-522045-21U1111-1323-2127
• Study Type: interventional
• Target: 69
• Locations: 3 countries
• Sites: 6

Brief Summary

This study is open to adults with advanced cancer (solid tumours) for whom previous treatment was not successful, or no treatment exists. The study tests different doses of BI 3810944 to find out which doses they can tolerate. Another purpose is to identify the most suitable dose of BI 3810944 and to find out whether it helps people with advanced cancer. BI 3810944 may help fight cancer. Participants get BI 3810944 usually once every 3 weeks. At treatment start, it is given once a week for a short time. Participants may continue to get BI 3810944 as long as they benefit from treatment but no longer than 2 years. During this time, they regularly visit the study site. The first study visits include overnight stays at the hospital. At the visits, study doctors check participants' health, take necessary laboratory tests, and note any unwanted effects. The doctors also regularly check the size of the tumour with imaging methods.

Conditions

Solid Tumours; Melanoma

Outcome Measures

Primary Outcomes (3)

• Part A (dose escalation): Occurrence of Cytokine Release Syndrome (CRS) Grade 1 or 2 during the Maximum Tolerated Dose (MTD) evaluation period

  approximately 2 months

• Part A (dose escalation): Occurrence of Dose Limiting Toxicity (DLTs) during the MTD evaluation period

  approximately 2 months

• Part B (dose expansion): Objective Response (OR)

  OR, defined as best overall response of confirmed CR and/or confirmed PR, where best overall response is determined according to RECIST v 1.1 assessed from first treatment administration until the earliest event of PD, death or last evaluable tumour assessment before start of subsequent anticancer therapy, loss to follow up or withdrawal of consent

  up to 24 months

Secondary Outcomes (9)

• Part A (dose escalation): Occurrence of DLTs during the on-treatment period

  approximately 2 months

• Part A (dose escalation): Occurrence of Adverse Event (AEs) during the on-treatment period

  approximately 2 months

• Part B (dose expansion): Occurrence of AEs during the on-treatment period

  up to 24 months

• Part B (dose expansion): Duration of Response (DoR)

  up to 24 months

• Part B (dose expansion): Disease control (DC)

  up to 24 months

Study Arms (2)

Part A: Dose escalation

EXPERIMENTAL

Drug: BI 3810944

Part B: Dose expansion

EXPERIMENTAL

Drug: BI 3810944

Interventions

BI 3810944 DRUG

BI 3810944

Part A: Dose escalation; Part B: Dose expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1
• 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)
• Age ≥18 years
• Adequate organ function
• Life expectancy of ≥3 months at the start of the trial treatment in the opinion of the investigator

You may not qualify if:

• 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
• 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
• 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
• Prior treatment with organ transplant or hematopoietic stem-cell transplant
• Anticoagulant treatment that cannot be safely interrupted based on opinion of the investigator if medically needed (e.g. biopsy)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (6)

University of Louisville

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

Tennessee Oncology, PLLC - Elliston Place Plaza DDU

Nashville, Tennessee, 37203, United States

RECRUITING

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

NOT YET RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

NOT YET RECRUITING

UZ Leuven

Leuven, 3000, Belgium

NOT YET RECRUITING

Radboud Universitair Medisch Centrum

Nijmegen, 6525 GA, Netherlands

NOT YET RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A: Dose escalation, Part B: Dose expansion

Study Record Dates

• First Submitted: November 3, 2025
• First Posted: November 4, 2025
• Study Start: February 24, 2026
• Primary Completion (Estimated): October 5, 2029
• Study Completion (Estimated): October 5, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); US (3); NL (1)