What side effects are associated with this type of intervention?

Immune system modulation and immune checkpoint inhibition therapies, such as those involving BI 765049 and ezabenlimab, commonly cause side effects like fatigue, skin reactions (rash, pruritus), gastrointestinal issues (diarrhea, colitis), and endocrine disorders (thyroid dysfunction, adrenal insufficiency). Severe immune-related adverse events, including pneumonitis, hepatitis, and nephritis, can also occur, with combination therapies potentially increasing the incidence and severity of these side effects.

What prior FDA approvals exist?

The FDA has approved several drugs that modulate the immune system and inhibit immune checkpoints for cancer treatment. Pembrolizumab and nivolumab are notable examples of PD-1 inhibitors approved for various cancers, including melanoma and non-small cell lung cancer. Ipilimumab, a CTLA-4 inhibitor, is approved for melanoma. Avelumab, another PD-1 inhibitor, is approved for Merkel cell carcinoma. These drugs enhance the immune system's ability to fight cancer by blocking inhibitory pathways that limit immune responses.

What other types of research exist?

Promising alternatives to BI 765049 and ezabenlimab for cancer treatment in 2024 include: 1) Pembrolizumab (Keytruda) - an anti-PD-1 therapy with extensive efficacy data in various cancers, including melanoma and gastric cancer. 2) Nivolumab (Opdivo) - another anti-PD-1 therapy, often used in combination with ipilimumab (anti-CTLA-4) for enhanced efficacy in melanoma and renal cell carcinoma. 3) Atezolizumab (Tecentriq) - an anti-PD-L1 therapy showing promise in urothelial carcinoma and non-small cell lung cancer. 4) Lenvatinib plus pembrolizumab - a combination therapy showing efficacy in renal cell carcinoma and endometrial cancer. These alternatives have demonstrated potential in clinical trials and may offer effective treatment options for patients with advanced solid tumors.

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Monoclonal Antibodies

BI 765049 + Ezabenlimab for Advanced Solid Cancers

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

Signed and dated, written informed consent form (ICF) (ICF1 for B7-H6 testing for all patients except those with advanced or metastatic colorectal cancer (CRC); and ICF2 for all patients) describing the study in accordance with International Council on Harmonisation Good Clinical Practice (ICH-GCP) and local legislation prior to any trial-specific procedures, sampling, or analyses.

Patient must be ≥18 years of age at the time of signature on the ICFs (ICF1 and ICF2).

Must not have

Patient with known leptomeningeal disease or spinal cord compression due to disease.

Presence of hepatitis B core (HBc) antibody together with hepatitis B virus (HBV)-DNA

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two new drugs that may help the immune system fight cancer in adults with advanced solid tumors that didn't respond to previous treatments. The drugs aim to boost the body's natural defenses to better attack cancer cells.

Who is the study for?

Adults with advanced solid tumors that have not responded to standard treatments can join this trial. Eligible cancers include colorectal, lung, liver, head and neck, stomach, and pancreatic cancers. Participants must have a specific tumor marker (B7-H6) or colorectal cancer and be in good enough health to undergo biopsies.

What is being tested?

The study is testing two drugs: BI 765049 alone and combined with ezabenlimab. It aims to find the highest dose patients can tolerate over up to three years of treatment given every three weeks via infusion. The effects on the immune system's ability to fight cancer are monitored along with tumor size.

What are the potential side effects?

Potential side effects from BI 765049 or ezabenlimab may include reactions related to the immune system attacking normal organs (autoimmune reactions), issues at the infusion site, fatigue, nausea, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I have signed the required consent forms for my participation in the study.

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I am 18 years old or older.

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I have advanced cancer that cannot be removed by surgery in specific areas like the colon, lung, liver, head and neck, stomach, or pancreas.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have cancer that has spread to the lining of my brain or spinal cord, or is pressing on my spinal cord.

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I have hepatitis B as shown by specific tests.

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I have not had extensive radiotherapy, including to the brain, in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Maximum tolerated dose (MTD) in any studied regimen

Number of patients with dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period

Secondary study objectives

Area under the concentration-time curve of BI 765049 over a uniform dosing interval τ (AUCτ)

Maximum measured concentration of BI 765049 (Cmax)

Objective response based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1) in patients with measurable disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: BI 765049 single treatment groupExperimental Treatment1 Intervention

BI 765049

Group II: BI 765049 + ezabenlimab combination treatment groupExperimental Treatment2 Interventions

BI 765049 + ezabenlimab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ezabenlimab

2018

Completed Phase 1

~260

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

Common cancer treatments, particularly those involving immune system modulation and immune checkpoint inhibition, work by enhancing the body's immune response against cancer cells. Immune system modulators stimulate or restore the immune system's ability to recognize and attack cancer cells. Immune checkpoint inhibitors, such as Ezabenlimab, block proteins that prevent immune cells from attacking cancer cells, thereby boosting the immune response. These mechanisms are crucial for cancer patients as they offer a more targeted approach, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Immunotherapeutic Targets and Therapy for Renal Cell Carcinoma.