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

NCT ID: NCT07224425

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-21
• Study Completion Date: 2029-10-05

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Dose escalation

Group Type: EXPERIMENTAL

BI 3810944

Intervention Type: DRUG

BI 3810944

Part B: Dose expansion

Group Type: EXPERIMENTAL

BI 3810944

Intervention Type: DRUG

BI 3810944

Interventions

BI 3810944

BI 3810944

Intervention Type: DRUG

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

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Louisville

Louisville, Kentucky, United States

Tennessee Oncology, PLLC - Elliston Place Plaza DDU

Nashville, Tennessee, United States

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

UZ Leuven

Leuven, , Belgium

Radboud Universitair Medisch Centrum

Nijmegen, , Netherlands

Countries

United States; Belgium; Netherlands

Central Contacts

Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Facility Contacts

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2025-522045-21

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1323-2127

Identifier Type: REGISTRY

Identifier Source: secondary_id

1527-0001

Identifier Type: -

Identifier Source: org_study_id