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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

NCT ID: NCT04958239

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-18

Study Completion Date

2028-05-23

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase 1 Arm A: BI 765179

Group Type EXPERIMENTAL

BI 765179

Intervention Type DRUG

BI 765179

Phase 1a Arm B: BI 765179 + ezabenlimab

Group Type EXPERIMENTAL

BI 765179

Intervention Type DRUG

BI 765179

Ezabenlimab

Intervention Type DRUG

Ezabenlimab

Phase 1b Cohort 1: pembrolizumab + low dose of BI 765179

Group Type EXPERIMENTAL

BI 765179

Intervention Type DRUG

BI 765179

Pembrolizumab

Intervention Type DRUG

Pembrolizumab

Phase 1b Cohort 2: pembrolizumab + high dose of BI 765179

Group Type EXPERIMENTAL

BI 765179

Intervention Type DRUG

BI 765179

Pembrolizumab

Intervention Type DRUG

Pembrolizumab

Interventions

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BI 765179

BI 765179

Intervention Type DRUG

Ezabenlimab

Ezabenlimab

Intervention Type DRUG

Pembrolizumab

Pembrolizumab

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

All cohorts:

* Patients with locally advanced, unresectable or metastatic solid tumors who are either refractory after standard therapy for the disease or for whom standard therapy is not appropriate
* Tumor with expected high expression of Fibroblast activation protein (FAP) of the following histologies:

* Non-small cell lung carcinoma (NSCLC)
* Gastric cancer
* Esophageal adenocarcinoma or squamous cell carcinoma
* Urothelial bladder carcinoma
* Head and neck squamous cell carcinoma
* Cutaneous malignant melanoma
* Cutaneous squamous cell carcinoma
* Hepatocellular carcinoma
* Pancreatic adenocarcinoma
* Colorectal cancer
* Malignant pleural mesothelioma
* Cervical squamous cell cancer
* Ovarian carcinoma
* Triple-negative breast cancer
* At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years
* Signed and dated, written informed consent (IC) in accordance with ICH-GCP and local legislation prior to admission to the trial
* At least one measurable lesion outside of central nervous system (CNS) as defined per modified Response evaluation criteria in solid tumors (RECIST) v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate liver, bone marrow and renal organ function
* Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. These methods must be used during the study and for at least 6 months after the last dose of the study medication. A list of contraception methods meeting these criteria is provided in the patient information.
* Patients with brain metastases are eligible provided they meet all of the following criteria:

* Brain metastases have adequately been treated and are considered stable by the Investigator
* Radiotherapy or surgery for brain metastases was completed at least 2 weeks prior to the first administration of BI 765179
* Patient is off steroids for at least 7 days (physiologic doses of steroids is permitted, if this was stable for the last 4 weeks)
* The patient is off anti-epileptic drugs for at least 7 days

Back-fill cohorts only:

* Patient has agreed to and signed an IC form to provide mandatory pre-treatment and on-treatment fresh tumor biopsy
* At least one lesion (separate from the evaluable target lesion outside of the CNS as defined per RECIST v1.1) that is accessible for mandatory paired pre and on-treatment biopsy

Phase 1b:

* Histologically or cytologically confirmed diagnosis of metastatic or incurable, recurrent head and neck squamous cell carcinoma (HNSCC)
* No prior systemic therapy administered in the metastatic or incurable, recurrent setting
* Primary tumor locations of oropharynx, oral cavity, hypopharynx, or larynx
* At least 18 years of age at the time of the consent or over the legal age of consent in countries where that is greater than 18 years

Exclusion Criteria

Phase 1a

* Currently enrolled in another investigational device or drug trial
* Previous or concomitant malignancies other than the one treated in this trial within the last 2 years except:

* Effectively treated non-melanoma skin cancers
* Effectively treated carcinoma in situ of the cervix
* Effectively treated ductal carcinoma in situ
* Other effectively treated malignancy that is considered cured by 'local treatment'
* Previous treatment with agents targeting CD137
* Known leptomeningeal disease or spinal cord compression due to disease
* Anticoagulant treatment that cannot be safely interrupted if medically needed (e.g., biopsy) based on the opinion of the Investigator
* Persistent toxicity from previous treatments that has not resolved to ≤ Common terminology criteria for adverse events (CTCAE) Grade 1 (except for alopecia, CTCAE Grade 2 neuropathy, asthenia/fatigue or grade 2 endocrinopathies controlled by replacement therapy)
* Patient has a diagnosis of immunodeficiency
* Patient with history of immunosuppressive medication within 14 days prior to the first dose of BI 765179. The following are exceptions to this criterion:

* Use of intranasal, inhaled, or topical corticosteroids, local steroid injections (e.g., intra-articular injections)
* Systemic corticosteroids at physiologic doses ≤10 mg/day (prednisone or equivalent)

Phase Ib

* Disease suitable for local therapy administered with curative intent
* Participants must not have a primary tumor site of nasopharynx or sino-nasal cancer or salivary gland cancers (any histology)
* Currently enrolled in another investigational device or drug trial
* Life expectancy of \<3 months and/or has rapidly progressing disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Arizona

Tucson, Arizona, United States

Site Status RECRUITING

Beverly Hills Cancer Center

Beverly Hills, California, United States

Site Status RECRUITING

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status NOT_YET_RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status NOT_YET_RECRUITING

NEXT Oncology-San Antonio-65273

San Antonio, Texas, United States

Site Status COMPLETED

Border Cancer Hospital

Albury, New South Wales, Australia

Site Status COMPLETED

Kinghorn Cancer Centre

Darlinghurst, New South Wales, Australia

Site Status RECRUITING

Townsville Hospital

Douglas, Queensland, Australia

Site Status NOT_YET_RECRUITING

Austin Hospital

Heidelberg, Victoria, Australia

Site Status RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status RECRUITING

Edegem - UNIV UZ Antwerpen

Edegem, , Belgium

Site Status NOT_YET_RECRUITING

AZ Groeninge

Kortrijk, , Belgium

Site Status RECRUITING

ICESP - Instituto do Cancer do Estado de Sao Paulo

São Paulo, , Brazil

Site Status RECRUITING

Hospital Sírio Libanês-São Paulo-68088

São Paulo, , Brazil

Site Status RECRUITING

Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, , Brazil

Site Status RECRUITING

The First Affiliated Hospital Of Bengbu Medical College

Bengbu, , China

Site Status NOT_YET_RECRUITING

Hunan Province Tumor Hospital

Changsha, , China

Site Status NOT_YET_RECRUITING

Fujian Cancer Hospital

Fuzhou, , China

Site Status RECRUITING

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Wuhan Union Hospital

Wuhan, , China

Site Status RECRUITING

Masaryk Memorial Cancer Institute

Brno, , Czechia

Site Status NOT_YET_RECRUITING

HOP Saint-André

Bordeaux, , France

Site Status NOT_YET_RECRUITING

CTR Georges-François Leclerc

Dijon, , France

Site Status RECRUITING

INS Cancérologie Ouest Saint-Herblain

Saint-Herblain, , France

Site Status NOT_YET_RECRUITING

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Martin-Luther-Universität Halle-Wittenberg

Halle, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Stuttgart

Stuttgart, , Germany

Site Status RECRUITING

Shaare-Zedek Medical Center, Oncology Institute

Jerusalem, , Israel

Site Status NOT_YET_RECRUITING

Sourasky Medical Center

Tel Aviv, , Israel

Site Status NOT_YET_RECRUITING

Istituto Nazionale IRCCS Tumori Fondazione Pascale

Napoli, , Italy

Site Status COMPLETED

Aichi Cancer Center Hospital

Aichi, Nagoya, , Japan

Site Status RECRUITING

National Cancer Center Hospital East

Chiba, Kashiwa, , Japan

Site Status RECRUITING

Kanagawa Cancer Center

Kanagawa, Yokohama, , Japan

Site Status NOT_YET_RECRUITING

Kansai Medical University Hospital

Osaka, Hirakata, , Japan

Site Status NOT_YET_RECRUITING

Osaka International Cancer Institute

Osaka, Osaka, , Japan

Site Status RECRUITING

Centro Oncologico Internacional

Mexico City, , Mexico

Site Status NOT_YET_RECRUITING

ARKE SMO S.A. de C.V

Mexico City, , Mexico

Site Status NOT_YET_RECRUITING

Instituto Nacional de Cancerologia

México, , Mexico

Site Status RECRUITING

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Fundación Santos y de la Garza Evia, I.B.P

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Investigacion Biomedica para el Desarrollo de Farmacos, S.A. de C.V.

Zapopan, , Mexico

Site Status NOT_YET_RECRUITING

VU University Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Erasmus Medisch Centrum-ROTTERDAM-50697

Rotterdam, , Netherlands

Site Status NOT_YET_RECRUITING

Gachon University Gil Medical Center

Incheon, , South Korea

Site Status NOT_YET_RECRUITING

CHA Bundang Medical Center

Seongnam, , South Korea

Site Status NOT_YET_RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Hospital Germans Trias i Pujol

Badalona, , Spain

Site Status RECRUITING

Hospital Universitari Vall D Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Clínico San Carlos

Madrid, , Spain

Site Status RECRUITING

Clínica Universidad de Navarra

Pamplona, , Spain

Site Status RECRUITING

Countries

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United States Australia Belgium Brazil China Czechia France Germany Israel Italy Japan Mexico Netherlands South Korea Spain

Central Contacts

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Boehringer Ingelheim

Role: CONTACT

Phone: 1-800-243-0127

Email: [email protected]

Facility Contacts

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Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

Role: primary

Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Boehringer Ingelheim

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Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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2021-000234-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-510307-22-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1310-6376

Identifier Type: REGISTRY

Identifier Source: secondary_id

1463-0001

Identifier Type: -

Identifier Source: org_study_id