Different doses of BI 3923948 alone and with an anti‑PD‑1 antibody for advanced solid tumors

Phase I Open-label Dose Escalation Trial of BI 3923948 Monotherapy and in Combination With an Anti-PD-1 mAb in Patients With Advanced, Unresectable and/or Metastatic Solid Tumors

This trial will test different doses of the new drug BI 3923948, given alone or with an anti‑PD‑1 antibody, in adults with recurrent or metastatic solid tumors that are accessible for injection and biopsy.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 10 sites (Indianapolis, Indiana and 9 other locations)
• Trial ID: NCT07395258 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, first‑in‑human dose‑finding trial of BI 3923948 given alone (Arm A) or together with the anti‑PD‑1 antibody ezabenlimab (Arm B). The study enrolls adults with recurrent or metastatic solid tumors that have progressed after prior therapy and have at least one accessible lesion for injection and biopsy. The main goals are to identify the highest dose patients can tolerate and to look for signs of anti‑tumor activity, with treatment given for defined periods and serial safety and tumor assessments. Eligible participants must have ECOG 0–1 and a life expectancy of at least three months; biopsies and injections are required as part of the protocol.

Who should consider this trial

Good fit: Adults with recurrent or metastatic solid tumors that have progressed on prior therapy, who have at least one accessible lesion for injection/biopsy, ECOG 0–1, and an expected survival of three months or more are ideal candidates.

Not a fit: Patients with untreated brain metastases, prior VSV‑based therapy, severe hypersensitivity to anti‑PD‑1 agents, or medical conditions that make injections unsafe are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the study could identify a tolerable dose of BI 3923948 that may shrink tumors alone or enhance responses when combined with an anti‑PD‑1 antibody.

How similar studies have performed: Combining oncolytic or intratumoral agents with anti‑PD‑1 therapy has shown promising responses in early‑phase studies, but BI 3923948 is being tested in humans for the first time so its effectiveness is unproven.

Eligibility criteria

Inclusion criteria:

1. Measurable disease as defined per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
2. Patient has 1 or more accessible lesions (2 or more preferred)
3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
4. Life expectancy of at least ≥3 months after the start of the treatment according to the investigator's judgement Further inclusion criteria apply.

Exclusion criteria:

1. 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
2. Previous treatment with vesicular stomatitis virus (VSV)-based agents
3. Concomitant medication or condition considered a high risk for complications from injection
4. History of common terminology criteria for adverse events (CTCAE) v5 grade 3 or higher severe hypersensitivity reactions to previous anti-programmed cell death 1 (anti-PD-1)/anti-programmed cell death ligand 1 (PD-L1) monoclonal antibody (mAb) (Arm B only) Further exclusion criteria apply.

Where this trial is running

Indianapolis, Indiana and 9 other locations

• Indiana University — Indianapolis, Indiana, United States (Not_yet_recruiting)
• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Not_yet_recruiting)
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States (Not_yet_recruiting)
• CTR Leon Berard — Lyon, France (Not_yet_recruiting)
• Institut Gustave Roussy — Villejuif, France (Not_yet_recruiting)
• Universitätsklinikum Heidelberg — Heidelberg, Germany (Not_yet_recruiting)
• Hospital Clínic de Barcelona — Barcelona, Spain (Not_yet_recruiting)
• Hospital Clinico De Valencia (INCLIVA) — Valencia, Spain (Not_yet_recruiting)
• Karolinska Universitetssjukhuset Stockholm — Stockholm, Sweden (Not_yet_recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Solid Tumors