BI 3923948 + Anti-PD-1 Antibody for Cancer

Not yet recruiting at 9 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Must not be taking: VSV-based agents

Disqualifiers: Brain tumors, Leptomeningeal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 3 months (BI 3923948), 1 year (checkpoint inhibitor)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new cancer treatment called BI 3923948, both alone and combined with a checkpoint inhibitor (anti-PD-1 antibody), to determine the tolerable dose for people with advanced cancer. It focuses on individuals whose cancer has spread and for whom other treatments have failed, with a life expectancy of at least 3 months. Participants will receive either the new treatment alone or with an added antibody designed to help the immune system fight cancer. Suitable candidates have advanced, injectable cancer that has spread and have not found success with other treatments. The trial requires regular visits to the study site, with close monitoring of health and tumor response. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications or have conditions that are considered high risk for complications from injections, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In previous studies, researchers aimed to find the highest dose of BI 3923948 that people with advanced cancer can tolerate. They sought to determine how much of the medicine could be administered without causing excessive side effects. Since BI 3923948 is being tested in humans for the first time, limited safety information is available. However, Phase 1 trials like this one typically focus on assessing the safety and side effects of the treatment.

When combined with ezabenlimab, a checkpoint inhibitor, some data is available. Studies have shown that side effects related to the treatment occurred in about 52% to 75% of patients who took both medicines together. This indicates that more than half of the participants experienced some side effects, which is important to consider when joining the trial. Overall, this trial remains in the early stages, concentrating on safety and determining the appropriate dose. Participants' health will be closely monitored to manage any potential side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BI 3923948 and its combination with ezabenlimab because these treatments offer a fresh approach to fighting cancer. Unlike traditional treatments like chemotherapy or standard immunotherapies, BI 3923948 targets specific cancer cell pathways, potentially reducing damage to healthy cells. When combined with ezabenlimab, an anti-PD-1 antibody, it may enhance the immune system's ability to detect and destroy cancer cells. This innovative mechanism could lead to more effective and less toxic cancer treatment options.

What evidence suggests that this trial's treatments could be effective for advanced cancer?

Research shows that BI 3923948 is being tested for advanced cancer by injecting it directly into tumors. The aim is to determine the safest dose for patients. This treatment is new and under study for the first time, so information from human trials is limited. However, early research suggests it might work by targeting specific cancer cells. In this trial, some participants will receive BI 3923948 as monotherapy.

Another arm of this trial uses BI 3923948 in combination with ezabenlimab, a checkpoint inhibitor. Checkpoint inhibitors help the immune system identify and attack cancer cells. Previous studies with similar drug combinations have shown promise in fighting cancer, with some success in certain types. The goal of the combination is to enhance the treatment's effectiveness in attacking cancer. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that have spread and are accessible for injection/biopsy can join this trial. It's for those who've had unsuccessful prior treatments or no available treatment, with a life expectancy of at least 3 months. Participants should be able to perform daily activities (ECOG score 0-1) and have measurable disease per RECIST 1.1.

Inclusion Criteria

My cancer can be measured by standard health scans.

My doctor believes I have at least 3 months to live.

I have at least one tumor that can be easily reached for treatment or biopsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 3923948 alone or in combination with a checkpoint inhibitor. BI 3923948 is given for up to 3 months, and the checkpoint inhibitor is given for up to 1 year.

3 months (BI 3923948), 1 year (checkpoint inhibitor)

Every 3 weeks, with additional visits in the first week of cycle 1

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 3923948
• Ezabenlimab

Trial Overview

The study tests the highest tolerable dose of BI 3923948 alone (Arm A) and combined with Ezabenlimab, an anti-PD-1 antibody (Arm B). Arm A receives BI 3923948 for up to three months; Arm B gets both drugs, with the antibody given for up to one year via infusion every three weeks.

How Is the Trial Designed?

Group I: Arm B: BI 3923948 in combination with ezabenlimab Experimental Treatment 2 Interventions

Group II: Arm A: BI 3923948 monotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07395258

A Study to Test Different Doses of BI 3923948 Alone and in ...

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 ...

2.

withpower.com

withpower.com/trial/phase-1-tumors-solid-2-2026-b5e7f

BI 3923948 + Anti-PD-1 Antibody for Cancer

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 ...

3.

synapse.patsnap.com

synapse.patsnap.com/drug/16818e3bddab41319186e3813447b14c

Ezabenlimab - Drug Targets, Indications, Patents

Treatment‐related adverse events (TRAEs) occurred in 52% and 75% of patients, respectively. BI 891065 plus ezabenlimab combination (USA study part B only) was ...

4.

ckb.genomenon.com

ckb.genomenon.com/clinicalTrial/show?nctId=NCT07395258

NCT07395258 : Clinical Trial Detail - CKB CORE - Genomenon

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 ...

5.

cancernetwork.com

cancernetwork.com/view/ezabenlimab-combo-yields-activity-in-advanced-squamous-cell-anal-carcinoma

Ezabenlimab Combo Yields Activity in Advanced ...

“[T]his phase 2 study met its primary endpoint, showing antitumor activity (clinical [CR] rates) and a manageable safety profile for ezabenlimab ...

6.

pro.boehringer-ingelheim.com

pro.boehringer-ingelheim.com/us/inoncology/our-pipeline/ezabenlimab

PD-1 inhibitor-ezabenlimab | InOncology

ezabenlimab is currently undergoing clinical investigations in combination with other anti-cancer therapies, for the treatment of various solid cancers. 1 ...