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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
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 belowSelect...
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:Select...
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
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
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.
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Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,380,114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken more than 10 mg of prednisone or equivalent daily in the last 3 weeks.I haven't taken any high-risk medications or have conditions that could complicate a biopsy recently.I have tried all known treatments for my condition without success.My blood clotting times are normal or I'm on a stable blood thinner dose.My cancer is advanced, cannot be removed by surgery, and may have spread or not responded to treatment.I have a tumor that can be biopsied.I haven't taken interferon, immunotherapy, or tamoxifen recently.I have been treated with VSV-based agents before.I have had brain metastases, but I am symptom-free after completing brain radiotherapy.I haven't had radiation on any area planned for biopsy in the last 6 months.My cancer diagnosis was confirmed through tissue examination.I have not had any major surgery in the last 4 weeks.I haven't had radiotherapy in the last 4 weeks, except for short-term pain relief or to prevent bone breaks.I do not have an active infection needing treatment as the trial starts.All side effects from my past cancer treatments are mild, except for hair loss and nerve pain which can be moderate.I am fully active or restricted in physically strenuous activity but can do light work.My recent lab tests show my organs and bone marrow are working well.My blood counts meet the required levels for the trial.My liver function tests are within the required range.
Research Study Groups:
This trial has the following groups:- Group 1: BI 1821736: Dose escalation cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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