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Immunotherapy

BI 1703880 + Ezabenlimab for Advanced Solid Tumors

Phase 1

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic or relapsed/refractory solid tumour. Patient must have at least one measurable lesion (according to Response Criteria in Solid Tumours (RECIST 1.1)).

Patient must have exhausted or refused established treatment options for the malignant disease, or is not eligible for established treatment options.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 804 days

Awards & highlights

Study Summary

This trial tests a new cancer treatment, BI 1703880 and ezabenlimab, for adults with advanced cancer. They get infusions every 3 weeks, and doctors check for side effects through regular visits.

Who is the study for?

Adults with advanced, hard-to-treat cancers can join this trial if previous treatments failed or aren't available. They need at least one measurable tumor and must be healthy enough for biopsies and other procedures. An ECOG score of 0-1 is required, indicating they are fully active or restricted in physically strenuous activity but ambulatory.Check my eligibility

What is being tested?

The trial tests the highest tolerable dose of BI 1703880 combined with Ezabenlimab, both immune system-boosting drugs given via vein infusion. Initially, BI 1703880 is weekly for six weeks then every three weeks; Ezabenlimab starts after three weeks and continues every three weeks up to two years.See study design

What are the potential side effects?

Potential side effects include reactions related to infusions, impact on organ function including liver issues due to increased enzymes (AST/ALT), blood disorders like low neutrophil or platelet counts, kidney function changes measured by eGFR rate, and possible autoimmune responses.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced, cannot be surgically removed, and has at least one measurable tumor.

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

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I agree to have two biopsies on a treatable lesion.

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I am healthy enough and agree to all required study procedures.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My recent lab tests show my organs and bone marrow are working well.

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My blood tests show enough neutrophils and platelets without needing growth factors recently.

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My kidney function, measured by eGFR, is normal or near normal.

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My liver function tests are within the required range.

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I am 18 years old or older, or meet the legal age of consent for my country.

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I have signed the consent form for this trial following all required guidelines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 804 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 804 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 804 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Occurrence of dose limiting toxicities (DLTs) during the maximum tolerated dose (MTD) evaluation period

Secondary outcome measures

Area under the concentration-time curve of BI 1703880 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

Maximum measured concentration of BI 1703880 in plasma (Cmax)

Occurrence of DLTs during the on-treatment period

Trial Design

1Treatment groups

Experimental Treatment

Group I: BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)Experimental Treatment2 Interventions

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,505 Previous Clinical Trials

11,340,226 Total Patients Enrolled

Media Library

BI 1703880 (Immunotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05471856 — Phase 1

Solid Tumors Research Study Groups: BI 1703880 (Cycle 1) then BI 1703880 + ezabenlimab (Cycle 2 onwards)

Solid Tumors Clinical Trial 2023: BI 1703880 Highlights & Side Effects. Trial Name: NCT05471856 — Phase 1

BI 1703880 (Immunotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05471856 — Phase 1

Frequently Asked Questions

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

Are patients currently able to join this experiment?

"Affirmative. According to clinicaltrials.gov, the study originally posted on January 19th 2023 is actively recruiting participants. 66 people are needed from 6 separate medical facilities for this research trial."

Answered by AI

Are there any health care centers executing this clinical trial in North America?

"This trial is currently welcoming participants from 6 different sites, which include Los Angeles, Barcelona and Valencia as well as other locations. Picking the closest site to you can be beneficial for reducing travel needs if you decide to join in on this study."

Answered by AI

To what extent could the combination of BI 1703880 and ezabenlimab be deleterious for participants?

"Given that BI 1703880 (Cycle 1) then BI 1703888 + ezabenlimab (Cycle 2 onwards) is in its initial testing phase, our team at Power has assessed it to have a safety rating of 1 on the scale from one to three. This indicates there are limited data points regarding efficacy and safety yet available."

Answered by AI

How many individuals are enrolled in this research project?

"Affirmative, clinicaltrials.gov indicates that this trial is actively recruiting participants. It was initially posted on January 19th 2023 and the details were last updated March 23rd of the same year. The study seeks to include 66 patients throughout 6 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)

2023. "A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05471856.