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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months

Awards & highlights

Study Summary

This trial is for adults with advanced solid tumours who have had no success with previous treatment. Participants will get a special virus (immunotherapy) to help their immune system fight cancer. Doctors will monitor their health and measure 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,880 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total roster of participants involved in this medical trial?

"Affirmative. According to clinicaltrials.gov, this experiment is currently enrolling participants; the initial posting date was May 25th 2023 and the most recent update was June 5th of the same year. The trial requires 27 patients from one medical site for completion."

Answered by AI

What risks are present for people taking BI 1821736: Dose escalation cohort?

"Our experts at Power have assigned a score of 1 to BI 1821736: Dose escalation cohort due to the limited data available that supports its safety and efficacy, as this is a Phase 1 trial."

Answered by AI

Could individuals still participate in this clinical experiment?

"Affirmative, the clinicaltrials.gov platform indicates that this trial is still accepting participants. The experiment was initially published on May 25th 2023 and modified most recently on June 5th of the same year. 27 individuals will be enrolled at a single medical centre for this research initiative."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer

2023. "A Study to Find a Suitable Dose of BI 1821736 and Test Whether it Helps People With Advanced Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05839600.