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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Boehringer Ingelheim
Study ID
NCT04958239
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Neoplasms

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 765179 — DRUG
    BI 765179
  • Ezabenlimab — DRUG
    Ezabenlimab
  • Pembrolizumab — DRUG
    Pembrolizumab

Study Details

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.

Key Dates

Start date
Oct 18, 2021
Status verified
May 2026
Primary completion
Apr 27, 2026
Completion
Feb 17, 2028

Study Design

Enrollment
151 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Arm A: BI 765179
  • Experimental: Phase 1a Arm B: BI 765179 + ezabenlimab
  • Experimental: Phase 1b Cohort 1: pembrolizumab + low dose of BI 765179
  • Experimental: Phase 1b Cohort 2: pembrolizumab + high dose of BI 765179

Primary Outcome Measure

Phase 1a: Maximum Tolerated Dose (MTD) [ Time Frame: Up to Day 21 (end of Cycle 1) ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of ArizonaTucsonArizona85719-
Beverly Hills Cancer CenterBeverly HillsCalifornia90211-
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Avera Cancer InstituteSioux FallsSouth Dakota57105-
NEXT Oncology-San Antonio-65273San AntonioTexas78229-

Find similar trials in Tucson, AZ

By research site
University of Arizona· Tucson, AZBeverly Hills Cancer Center· Beverly Hills, CAThe University of North Carolina at Chapel Hill· Chapel Hill, NCAvera Cancer Institute· Sioux Falls, SDNEXT Oncology-San Antonio-65273· San Antonio, TX

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