What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly immunotherapies like oncolytic virus immunotherapy (e.g., BI 1821736), often include immune checkpoint inhibitors and other forms of immunotherapy. Known side effects of these treatments can include flu-like symptoms, fatigue, fever, chills, nausea, and injection site reactions. More serious adverse effects may involve immune-related reactions such as colitis, pneumonitis, hepatitis, endocrinopathies, and neurological toxicities. Regular monitoring by healthcare providers is essential to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of solid tumors, including immune checkpoint inhibitors like pembrolizumab and nivolumab, which are used for various cancers such as melanoma and lung cancer. Additionally, talimogene laherparepvec (T-VEC) is an FDA-approved oncolytic virus specifically for the treatment of melanoma. These therapies, similar to BI 1821736, leverage the body's immune system to target and destroy cancer cells.

What other types of research exist?

Promising novel alternatives to BI 1821736 for solid tumor patients include: 1) BI 836826, an anti-CD37 monoclonal antibody, especially in combination with gemcitabine and oxaliplatin for relapsed/refractory diffuse large B-cell lymphoma. 2) Pembrolizumab, an anti-PD-1 antibody, which has shown efficacy in various solid tumors, including melanoma and mesothelioma. 3) Nivolumab combined with ipilimumab, which has demonstrated effectiveness in treating malignant pleural mesothelioma and metastatic melanoma. 4) Tremelimumab combined with durvalumab, which is being studied for its potential in mesothelioma treatment.

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Virus Therapy

Immunotherapy with BI 1821736 for Advanced Cancer

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 confirmed diagnosis of malignant tumor

Advanced, unresectable and/or metastatic or relapsed/refractory solid tumors

Must not have

Previous treatment with Vesicular Stomatitis Virus (VSV)-based agents

Prior (within 3 weeks of first dose) or concomitant use of systemic corticosteroids (>10 mg daily prednisone or equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is for adults with advanced solid tumors who have no other treatment options. It tests a new medicine called BI 1821736, which uses a virus to kill cancer cells and boost the immune system. Participants receive the medicine regularly, and doctors monitor their health and any side effects.

Who is the study for?

Adults with advanced solid tumors that have not responded to previous treatments or for whom no treatment is available can join this trial. They must have a tumor lesion suitable for biopsy, normal blood clotting levels, and resolved side effects from past cancer therapies (except certain conditions). Participants need good organ function and an acceptable level of blood cells.

What is being tested?

The trial is testing BI 1821736, a new immunotherapy given as an infusion every three weeks up to three months. It's the first time humans receive this virus-based therapy designed to kill cancer cells and boost the immune system. The highest tolerable dose will be determined while monitoring health and tumor response.

What are the potential side effects?

Potential side effects are not fully known since it's the first human trial of BI 1821736 but may include typical reactions related to immunotherapies such as flu-like symptoms, fatigue, allergic reactions at the infusion site, or other immune-related issues.

Eligibility Criteria

Inclusion Criteria

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

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My cancer diagnosis was confirmed through tissue examination.

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My cancer is advanced, cannot be removed by surgery, and may have spread or not responded to treatment.

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

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I have a tumor that can be biopsied.

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

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My blood counts meet the required levels for the trial.

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My liver function tests are within the required range.

Exclusion Criteria

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

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I have been treated with VSV-based agents before.

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I have not taken more than 10 mg of prednisone or equivalent daily in the last 3 weeks.

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I do not have an active infection needing treatment as the trial starts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months

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

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

Secondary study objectives

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

Occurrence of DLTs during the on-treatment period

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: BI 1821736: Dose escalation cohortExperimental Treatment1 Intervention

0 / 10Eligibility 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

BI 1821736 is an oncolytic virus immunotherapy that works by selectively infecting and killing cancer cells while also stimulating the immune system to attack the tumor. This dual mechanism is particularly beneficial for solid tumor patients as it not only directly reduces tumor size but also enhances the body's natural immune response against cancer. Other common treatments for solid tumors include immune checkpoint inhibitors, which block proteins that prevent the immune system from attacking cancer cells, and targeted therapies that focus on specific genetic mutations within the tumor. These treatments are crucial as they offer more personalized and potentially effective options compared to traditional chemotherapy, which non-selectively kills rapidly dividing cells and often results in significant side effects.

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