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NCT04958239 · ClinicalTrials.gov registry record · Phase 1

A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer

A Phase 1 study of Neoplasms, sponsored by Boehringer Ingelheim.

Active
Registry status
Phase 1
Development phase
151
Enrollment target
20
Study locations

NCT04958239 is a Phase 1 study of Neoplasms that is active but no longer recruiting, run by Boehringer Ingelheim. The registered enrollment target is 151 participants, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 9 states.

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The verdict

NCT04958239, a Phase 1 study of Neoplasms, is active but no longer recruiting, sponsored by Boehringer Ingelheim.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
151 participants
Enrollment target
20
Study locations

Study Summary

This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. The goal of Part 2 is to find out whether BI 765179 in combination with a medicine called pembrolizumab helps people with advanced head and neck cancer. In Part 1, each participant is put into 1 of 2 groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. In Part 2, participants are also divided into 2 groups. 1 group gets a low dose of BI 765179 in combination with pembrolizumab and the other group gets a high dose of BI 765179 in combination with pembrolizumab. Participants receive the study treatment as infusions into a vein. BI 765179, ezabenlimab, and pembrolizumab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time. Participants can stay in the study up to 2 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.

Conditions Studied

Neoplasms

Interventions

  • DRUG Pembrolizumab
  • DRUG Ezabenlimab
  • DRUG BI 765179

Study Locations (20)

Other

  • Cliniques Universitaires Saint-Luc - Brussels
  • Edegem - UNIV UZ Antwerpen - Edegem
  • AZ Groeninge - Kortrijk
  • ICESP - Instituto do Cancer do Estado de Sao Paulo - São Paulo
  • Hospital Sírio Libanês-São Paulo-68088 - São Paulo
  • Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência - São Paulo
  • The First Affiliated Hospital Of Bengbu Medical College - Bengbu
  • Hunan Province Tumor Hospital - Changsha
  • Fujian Cancer Hospital - Fuzhou
  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University - Guangzhou
  • Wuhan Union Hospital - Wuhan

New South Wales

  • Border Cancer Hospital - Albury
  • Kinghorn Cancer Centre - Darlinghurst

Arizona

  • University of Arizona - Tucson

California

  • Beverly Hills Cancer Center - Beverly Hills

North Carolina

  • The University of North Carolina at Chapel Hill - Chapel Hill

South Dakota

  • Avera Cancer Institute - Sioux Falls

Texas

  • NEXT Oncology-San Antonio-65273 - San Antonio

Queensland

  • Townsville Hospital - Douglas

Trial Details

FieldValue
Enrollment Target 151 participants
Start Date 2021-10-18
Est. Completion 2028-02-17
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 NCT04958239

The ClinicalTrials.gov registry entry for NCT04958239 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 151 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,620-participant average among 158 other Neoplasms trials with a reported enrollment target (91% lower). The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.

NCT04958239 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, New South Wales, Arizona.

Frequently Asked Questions

What is clinical trial NCT04958239 about?

NCT04958239 is a clinical study titled "A Study to Test BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) and BI 765179 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Cancer". This study is open to adults with advanced cancer (solid tumors) and people with advanced head and neck cancer. The study has 2 parts. The purpose of Part 1 of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or togethe...

What is the current status of trial NCT04958239?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 151 participants. The study started on 2021-10-18. Estimated completion is 2028-02-17.

What conditions does trial NCT04958239 study?

This clinical trial studies the following conditions: Neoplasms.

What interventions are being tested in trial NCT04958239?

The interventions under investigation include: Pembrolizumab (DRUG), Ezabenlimab (DRUG), BI 765179 (DRUG).

Who is sponsoring clinical trial NCT04958239?

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

Where is trial NCT04958239 being conducted?

This trial has 20 study locations across Arizona, California, North Carolina, South Dakota, Texas. 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.