What side effects are associated with this type of intervention?

Checkpoint inhibitors, such as BI 770371 and Ezabenlimab, commonly cause immune-related adverse events due to their mechanism of enhancing immune activity. These side effects can affect various organs, leading to conditions like pneumonitis, colitis, hepatitis, endocrinopathies (e.g., thyroiditis, adrenal insufficiency), and skin reactions (e.g., rash, pruritus). Severe side effects, including grade 3 to 5 events, may necessitate discontinuation of treatment and the use of immunosuppressive therapy.

What prior FDA approvals exist?

FDA-approved checkpoint inhibitors for the treatment of solid tumors include Pembrolizumab (Keytruda), Nivolumab (Opdivo), and Atezolizumab (Tecentriq). These drugs target the PD-1/PD-L1 pathways to boost the immune system's ability to fight cancer. They have been approved for various types of solid tumors such as non-small cell lung cancer, melanoma, renal cell carcinoma, and head and neck cancers. These treatments are similar to the investigational drugs BI 770371 and Ezabenlimab being studied for their efficacy and tolerability in advanced cancer patients.

What other types of research exist?

Promising novel alternatives to BI 770371 and Ezabenlimab for solid tumor patients in 2024 include: 1) Pembrolizumab and Nivolumab, which are well-established checkpoint inhibitors with ongoing research into new combinations and indications. 2) Relatlimab, a newer checkpoint inhibitor targeting LAG-3, often combined with Nivolumab. 3) Avelumab, another checkpoint inhibitor showing efficacy in various solid tumors. 4) Combination therapies involving checkpoint inhibitors with other agents like targeted therapies (e.g., Dabrafenib plus Trametinib for BRAF-mutated tumors) or novel immunotherapies (e.g., CAR-T cells, bispecific antibodies).

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Checkpoint Inhibitor

BI 770371 + 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

Eastern Cooperative Oncology Group (ECOG) Score: 0 to 1

Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type)

Must not have

Major surgery (major according to the Investigator's assessment) performed within 12 weeks prior to randomisation or planned within 12 months after screening, e.g. hip replacement

Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Summary

This trial is for adults with advanced cancer who have no other treatment options. It tests BI 770371 alone or with ezabenlimab, which help the immune system fight cancer. The treatments are given periodically through a drip.

Who is the study for?

Adults with advanced solid tumors who have not had success with previous treatments or have no other treatment options can join this study. They must be over 18, able to consent, and have a life expectancy of at least 3 months. Participants should not have active brain metastases or severe allergies to trial drugs.

What is being tested?

The trial is testing the highest tolerable dose of BI 770371 alone or combined with ezabenlimab in adults with advanced cancer. Both are antibodies that may boost the immune system's ability to fight cancer. Treatments are given as infusions every three weeks for up to two years if beneficial.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (immune-related adverse events), infusion reactions, fatigue, and potentially others not listed here due to these being new treatments.

Eligibility Criteria

Inclusion Criteria

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

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

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I have an advanced cancer that cannot be removed by surgery.

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I have tried all known treatments for my condition without success.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had, nor plan to have, any major surgeries like a hip replacement around the trial period.

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I need to keep taking certain medications that may affect the trial's safety.

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I have had lung inflammation or interstitial lung disease in the past 5 years.

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I've had severe allergic reactions to other antibody treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in combination therapy

Occurrence of Dose Limiting Toxicities (DLTs) in the Maximum Tolerated Dose (MTD) evaluation period in monotherapy

Secondary study objectives

Occurrence of Adverse Events (AEs) during the on-treatment period in combination therapy

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

Occurrence of Dose Limiting Toxicities (DLTs) during the on-treatment period in combination therapy

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy dose escalationExperimental Treatment1 Intervention

Group II: Combination therapy dose escalationExperimental Treatment2 Interventions

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Checkpoint inhibitors, such as BI 770371 and Ezabenlimab, are a form of immunotherapy that enhance the immune system's ability to fight cancer by blocking proteins that inhibit immune responses. These drugs target checkpoints like PD-1/PD-L1 or CTLA-4, allowing T-cells to attack and destroy cancer cells more effectively. This mechanism is crucial for patients with solid tumors, as it provides a promising treatment option, particularly for those who have not responded to conventional therapies.

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