A Study to Test Different Doses of BI 3968621 When Given Alone or With Ezabenlimab in Patients With Advanced Cancer

NCT07851103 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: 2010-00012026-526199-22-00U1111-1337-3740
• Study Type: interventional
• Target: 90
• Locations: 5 countries
• Sites: 10

Brief Summary

This study is open to adults with advanced cancer that cannot be removed by surgery or have spread to other parts of the body. The purpose of this study is to find the highest and most suitable dose of BI 3968621 that people with advanced cancer can tolerate when taken alone or with ezabenlimab. Another purpose is to find out if taking these medicines can stop tumours from growing or make tumours shrink. In this study, BI 3968621 is given to people for the first time. The study is done in 3 parts. The parts are called Part A, Part A2, and Part B. Participants get BI 3968621 alone or in combination with ezabenlimab depending on which part they are in. Part A is done to find the highest and the most suitable dose of BI 3968621 that people with advanced cancer can tolerate. Part A2 is done to find out if taking BI 3968621, at certain dose levels, can stop or slow down tumour growth in participants with kidney cancer. Part B is done to find out how BI 3968621 is tolerated when given with ezabenlimab. BI 3968621 is taken daily as tablets. Ezabenlimab is given as an infusion into a vein once every 3 weeks. Participants can receive study treatment for up to 2 years if they benefit and can tolerate it. During this time, they visit the study site regularly. The number of visits depends on how participants respond to and tolerate the study treatment. Researchers look at the number of participants with certain severe health problems that happen within 3 weeks after the first study treatment. The study doctors check participants' health, take note of unwanted effects, take blood samples, and check how the cancer responds to study treatment.

Conditions

Advanced Solid Tumour

Outcome Measures

Primary Outcomes (2)

• Occurrence of dose-limiting toxicities (DLTs) during the primary DLT evaluation period (Dose escalation part A and B)

  During the first treatment cycle, up to 21 days

• Objective response (OR)

  defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), where BOR is determined by investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 from first administration until earliest of disease progression, death or last evaluable tumour assessment before start of subsequent anticancer therapy, lost to follow-up, or withdrawal of consent, whichever occurs first (Part A2)

  Up to 2 years

Secondary Outcomes (16)

• Occurrence of treatment-emergent adverse events (AEs)

  Up to 2 years

• Occurrence of dose-limiting toxicities (DLTs)

  Up to 2 years

• Occurrence of drug-related AEs

  Up to 2 years

• Occurrence of treatment-emergent serious adverse events (SAEs)

  Up to 2 years

• Objective response (OR)

  Up to 2 years

Study Arms (3)

BI 3968621 dose escalation monotherapy (Part A)

EXPERIMENTAL

Drug: BI 3968621

BI 3968621 dose expansion monotherapy (Part A2)

EXPERIMENTAL

Drug: BI 3968621

BI 3968621 + ezabenlimab dose escalation combination therapy (Part B)

EXPERIMENTAL

Drug: BI 3968621; Drug: ezabenlimab

Interventions

BI 3968621 DRUG

BI 3968621

BI 3968621 + ezabenlimab dose escalation combination therapy (Part B); BI 3968621 dose escalation monotherapy (Part A); BI 3968621 dose expansion monotherapy (Part A2)

ezabenlimab DRUG

ezabenlimab

BI 3968621 + ezabenlimab dose escalation combination therapy (Part B)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

Florida Cancer Specialists-Sarasota-61670

Sarasota, Florida, 34232, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Sarah Cannon Research Institute-Nashville-48456

Nashville, Tennessee, 37203, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

Institut Gustave Roussy

Villejuif, 94800, France

Location

Japanese Foundation for Cancer Research

Tokyo, Koto-ku, 135-8550, Japan

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinico De Valencia (INCLIVA)

Valencia, 46010, Spain

Location

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

018002430127; clintriage.rdg@boehringer-ingelheim.com

Study Design

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

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: October 1, 2026
• Study Start (Estimated): October 26, 2026
• Primary Completion (Estimated): September 3, 2030
• Study Completion (Estimated): September 3, 2030
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

FR (1); US (5); ES (2); BE (1); JP (1)