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Monoclonal Antibodies

BI 1387446 + Ezabenlimab for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have exhausted established treatment options known to prolong survival for the malignant disease, or is not eligible for established treatment options

Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic malignant solid tumor and indication for treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up an average of 1 year

Awards & highlights

Study Summary

This trial is testing two cancer treatments to see if they can help the immune system fight the disease. one of the treatments is being given to humans for the first time. The study will last for up to two years and eight months, during which time patients will visit the study site regularly to document any side effects and check for health improvements.

Who is the study for?

This trial is for adults with advanced solid tumors where previous treatments failed. Participants must have at least one tumor suitable for injection and another that can be biopsied, excluding the brain, mediastinum or pancreas. They should have no other treatment options left, good organ function, and be able to undergo all trial procedures.Check my eligibility

What is being tested?

The study tests two immune system-boosting medicines: BI 1387446 (injected into the tumor) and BI 754091 (infused into a vein). The goal is to find the highest tolerable dose of BI 1387446 alone or combined with BI 754091. Treatment can continue up to nearly three years if beneficial.See study design

What are the potential side effects?

Potential side effects may include typical immune-related reactions such as inflammation in various organs, infusion reactions from the drugs entering your body through a vein, fatigue, possible infection risks due to immune system changes, and any general discomfort associated with injections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have tried all known treatments for my cancer or am not eligible for them.

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My cancer is advanced, cannot be surgically removed, and needs treatment.

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I have at least one tumor outside my brain, chest center, or pancreas that can be biopsied.

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I have a tumor that can be injected and measured for treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum tolerated dose (MTD) based on number of Dose-limiting toxicities (DLTs)

Number of patients with Dose limiting Toxicity (DLT) in the Maximum tolerated dose (MTD) evaluation period

Secondary outcome measures

Best percentage change from baseline in size of injected target lesions

Best percentage change from baseline in size of non-injected target lesions

Objective response

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm B: BI 1387446 in combination with ezabenlimab (BI 754091)Experimental Treatment2 Interventions

superficial lesions

Group II: Arm A: BI 1387446Experimental Treatment1 Intervention

superficial lesions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 754091

2018

Completed Phase 1

~520

BI 1387446

2020

Completed Phase 1

~40

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,505 Previous Clinical Trials

11,340,253 Total Patients Enrolled

3 Trials studying Tumors

1,624 Patients Enrolled for Tumors

Media Library

BI 1387446 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04147234 — Phase 1

Tumors Research Study Groups: Arm B: BI 1387446 in combination with ezabenlimab (BI 754091), Arm A: BI 1387446

Tumors Clinical Trial 2023: BI 1387446 Highlights & Side Effects. Trial Name: NCT04147234 — Phase 1

BI 1387446 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04147234 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being sought for this experiment?

"The sponsor, Boehringer Ingelheim requires 120 compliant patients to run the clinical trial at two distinct locations: The University of North carolina in Chapel Hill and Froedtert & The Medical College of Wisconsin located in Milwaukee."

Answered by AI

Are there any safety concerns associated with BI 1387446 treatment?

"Due to its position in the first stage of clinical trials, BI 1387446 is currently deemed a 1 on Power's safety scale as data has yet to be collected for efficacy and safety."

Answered by AI

Are there any vacancies available for participants in this clinical trial?

"Affirmative. The information available on clinicaltrials.gov indicates that this medical research, which was created March 9th 2020, is now actively seeking candidates. A total of 120 patients are being sought across 3 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)

2020. "A Study to Find the Best Dose of BI 1387446 Alone or in Combination With Ezabenlimab (BI 754091) in Patients With Different Types of Advanced or Metastatic Cancer (Solid Tumors)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04147234.