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NCT05155332 · ClinicalTrials.gov registry record · Phase 1

A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)

A Phase 1 study of Solid Tumors, sponsored by Boehringer Ingelheim.

Recruiting
Registry status
Phase 1
Development phase
190
Enrollment target
20
Study locations

NCT05155332 is a Phase 1 study of Solid Tumors that is actively recruiting participants, run by Boehringer Ingelheim. The registered enrollment target is 190 participants, below the 283-participant average among 125 other Solid Tumors trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT05155332, a Phase 1 study of Solid Tumors, is actively recruiting participants, sponsored by Boehringer Ingelheim.

RECRUITING
Registry status
Phase 1
Development phase
190 participants
Enrollment target
20
Study locations

Study Summary

This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medicine called BI 1831169 that people with advanced cancer can tolerate when taken with or without a type of antibody called a checkpoint inhibitor (anti-PD-1 antibody). Another purpose is to check whether the study treatment can fight cancer. In this study, BI 1831169 is given to people for the first time. This study has 2 parts. In Part 1, participants get BI 1831169 alone for up to 3 months. In Part 2, participants get BI 1831169 in combination with a checkpoint inhibitor. Participants who take the combination treatment get BI 1831169 for up to 3 months and a checkpoint inhibitor for up to 1 year. BI 1831169 is given as an injection into the tumor, or as an infusion into the vein, or both (injection and infusion). Checkpoint inhibitors are given as an infusion into a vein. Participants get the medicines about every 3 weeks. This is called a treatment cycle. Participants visit the site study site regularly. The number of study visits vary based on the study phase and treatment response. Some visits include an overnight stay. The doctors regularly check the participants' health and monitor the tumors. The doctors also take note of any health problems that could have been caused by the study treatment.

Conditions Studied

Solid Tumors

Interventions

  • DRUG BI 1831169
  • DRUG anti-PD-1 antibody

Study Locations (20)

Other

  • Medical University of Innsbruck - Innsbruck
  • Salzburg Cancer Research Institute - Salzburg
  • Edegem - UNIV UZ Antwerpen - Edegem
  • Universitair Ziekenhuis Gent - Ghent

Arizona

  • Banner MD Anderson Cancer Center-Gilbert-55251 - Gilbert
  • University of Arizona - Tucson

California

  • University of California San Diego - La Jolla
  • Providence St. John's Health Center - Santa Monica

Florida

  • University of Miami - Miami
  • Orlando Health Cancer Institute - Orlando

Colorado

  • University of Colorado Denver - Aurora

Georgia

  • Winship Cancer Institute - Atlanta

Kentucky

  • University of Louisville - Louisville

Minnesota

  • M Health Fairview University of Minnesota Medical Center - Minneapolis

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2022-03-28
Est. Completion 2028-10-31
Phase Phase 1

Sponsor

Boehringer Ingelheim

515 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05155332

The ClinicalTrials.gov registry entry for NCT05155332 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 190 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 283-participant average among 125 other Solid Tumors trials with a reported enrollment target (33% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Solid Tumors appearing as the primary indexed condition, and to 2 interventions - of which BI 1831169 is the first listed.

NCT05155332 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT05155332 about?

NCT05155332 is a clinical study titled "A Study to Test Different Doses of BI 1831169 Alone and in Combination With an Anti-PD-1 Antibody in People With Different Types of Advanced Cancer (Solid Tumors)". This study is open to adults with different types of advanced cancer (solid tumors) that are accessible for injection and/or biopsy. This is a study for people with a life expectancy of at least 3 months after starting study treatment. The purpose of this study is to find the highest dose of a medic...

What is the current status of trial NCT05155332?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 190 participants. The study started on 2022-03-28. Estimated completion is 2028-10-31.

What conditions does trial NCT05155332 study?

This clinical trial studies the following conditions: Solid Tumors.

What interventions are being tested in trial NCT05155332?

The interventions under investigation include: BI 1831169 (DRUG), anti-PD-1 antibody (DRUG).

Who is sponsoring clinical trial NCT05155332?

This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05155332 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.