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New antibody combo shows promise in early cancer trial

NCT ID NCT04958239

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 20, 2026 · Updated 10 times

Summary

This early-phase trial tests a new drug called BI 765179, an antibody that helps the immune system fight cancer. It is given alone or with other drugs (ezabenlimab or pembrolizumab) to adults with advanced solid tumors or head and neck cancer. The study aims to find the best dose and see if the combination shrinks tumors. Participants are monitored for up to 2 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 765179 (an antibody that may help the immune system fight cancer)
What this could lead to
If it works, this could point toward a new treatment option for advanced solid tumors and head and neck cancer.
What could go wrong
This is an early Phase I trial with a small number of participants, so it may not lead to a proven treatment. Side effects are possible and being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

151 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 * Signed and dated written IC in accordance with ICH-GCP and local legislation prior to admission to the trial Further inclusion criteria apply 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) * Physiological replacement dose of corticosteroids Further exclusion criteria apply. 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 * Diagnosed and/or treated additional malignancy within 2 years prior to randomization with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or curatively resected in situ cervical and/or in situ breast cancers Further exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

head and neck squamous cell carcinoma neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neoplasms

Contacts and locations

Locations

  • AZ Groeninge

    Kortrijk, 8500, Belgium

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, 510095, China

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, 01321-001, Brazil

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211, United States

  • Border Cancer Hospital

    Albury, New South Wales, 2640, Australia

  • CHA Bundang Medical Center

    Seongnam, 13496, South Korea

  • CTR Georges-François Leclerc

    Dijon, 21079, France

  • Centro Oncologico Internacional

    Mexico City, 04700, Mexico

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Clínica Universidad de Navarra

    Pamplona, 31008, Spain

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 GD, Netherlands

  • Fujian Cancer Hospital

    Fuzhou, 350014, China

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

    Monterrey, 66278, Mexico

  • Gachon University Gil Medical Center

    Incheon, 21565, South Korea

  • HOP Saint-André

    Bordeaux, 33075, France

  • Hospital Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 08916, Spain

  • Hospital Sírio Libanês-São Paulo-68088

    São Paulo, 01308050, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460, Mexico

  • Hunan Province Tumor Hospital

    Changsha, 410013, China

  • ICESP - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000, Brazil

  • INS Cancérologie Ouest Saint-Herblain

    Saint-Herblain, 44805, France

  • Instituto Nacional de Cancerologia

    México, 14080, Mexico

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Naples, 80131, Italy

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515, Japan

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191, Japan

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010, Australia

  • Klinikum Stuttgart

    Stuttgart, 70174, Germany

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06120, Germany

  • Masaryk Memorial Cancer Institute

    Brno, 65653, Czechia

  • NEXT Oncology-San Antonio-65273

    San Antonio, Texas, 78229, United States

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Shaare-Zedek Medical Center, Oncology Institute

    Jerusalem, 9103102, Israel

  • Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004, China

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • Townsville Hospital

    Douglas, Queensland, 4814, Australia

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430022, China

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650, Belgium

  • University of Arizona

    Tucson, Arizona, 85719, United States

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • VU University Medical Center

    Amsterdam, 1081HV, Netherlands

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