A Study to Test Different Doses of BI 3923948 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

NCT07395258 | Suspended Phase 1 DMC FDA Drug

• 3 other identifiers: 1538-0001U1111-1319-80462025-521438-27-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is open to adults aged 18 and over or above legal age with different types of recurrent advanced cancer (solid tumors) that have spread to other parts of the body and that are accessible for injection and biopsy. This is a study for people for whom previous treatment was not successful or no treatment exists, with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 3923948, that people with advanced cancer can tolerate, when taken alone and together with a type of antibody called a checkpoint inhibitor (anti-programmed cell death protein 1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 3923948 is given to people for the first time. This study has 2 arms. In Arm A, participants get BI 3923948 alone for up to 3 months. In Arm B, participants get BI 3923948 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 3923948 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 3923948 is given as injection(s) into the tumor, and the checkpoint inhibitor is given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Only in treatment cycle 1 will participants get BI 3923948 twice in the first week. Participants visit the site study site regularly. The number of study visits vary based on the study arm and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors closely check the health of the participants and also take note of any health problems that could have been caused by the study treatment.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Occurrence of Dose-limiting toxicities (DLTs) during the primary DLT evaluation period

  up to 3 weeks

Secondary Outcomes (2)

• Occurrence of DLTs during the on-treatment period

  up to 12 months

• Occurrence of Adverse Events (AEs) during the on-treatment period

  up to 12 months

Study Arms (2)

Arm A: BI 3923948 monotherapy

EXPERIMENTAL

Drug: BI 3923948

Arm B: BI 3923948 in combination with ezabenlimab

EXPERIMENTAL

Drug: BI 3923948; Drug: Ezabenlimab

Interventions

BI 3923948 DRUG

BI 3923948

Arm A: BI 3923948 monotherapy; Arm B: BI 3923948 in combination with ezabenlimab

Ezabenlimab DRUG

Ezabenlimab

Arm B: BI 3923948 in combination with ezabenlimab

Eligibility Criteria

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

You may qualify if:

• Measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Patient has 1 or more accessible lesions (2 or more preferred)
• Eastern Cooperative Oncology Group (ECOG) score of 0 or 1

You may not qualify if:

• Patients with known primary brain tumors, leptomeningeal disease or untreated brain metastases. Subjects with previously treated brain metastases may participate provided the brain metastases are stable
• Previous treatment with vesicular stomatitis virus (VSV)-based agents
• Concomitant medication or condition considered a high risk for complications from injection

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Links

• Related Info

Study Design

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

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: February 9, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): February 20, 2028
• Study Completion (Estimated): February 12, 2032
• Last Updated: June 4, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)