Skip to main content

An Open Label, Phase I Dose-finding and Expansion Study of BI 765179 as Monotherapy and in Combination With Ezabenlimab (BI 754091) in Patients With Advanced Solid Cancers, and BI 765179 in Combination With Pembrolizumab in First-line PD-L1-positive Metastatic or Incurable, Recurrent Head and Neck Squamous Cell Carcinoma (HNSCC)

  • NCT04958239
  • PHASE1
  • INTERVENTIONAL

Last updated: 2024-08-27

Purpose of  Trial

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 3 years (Part 1) or 2 years (Part 2) 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.


This study is for people with

Neoplasms


Interventions being studied

BI 765179

Ezabenlimab

Register to Save
ELIGIBILITY

Gender: ALL

Age: 18+

Healthy Volunteers: No

2 Locations
Tucson

University of Arizona


Arizona, 85719, United States
San Antonio

NEXT Oncology


Texas, 78229, United States
Primary Contact(s)

Boehringer Ingelheim

Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at ClinicalTrials.gov

Back to Results New Search