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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 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

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.
Immunotherapy for malignant pleural mesothelioma: current status and future directions.Emerging and mechanism-based therapies for recurrent or metastatic Merkel cell carcinoma.

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,549 Previous Clinical Trials
15,769,033 Total Patients Enrolled

Media Library

BI 1821736 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05839600 — Phase 1
Solid Tumors Research Study Groups: BI 1821736: Dose escalation cohort
Solid Tumors Clinical Trial 2023: BI 1821736 Highlights & Side Effects. Trial Name: NCT05839600 — Phase 1
BI 1821736 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05839600 — Phase 1
~0 spots leftby Nov 2024