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NeoplasmsPhase 1NCT04958239

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 testing BI 765179, Ezabenlimab and Pembrolizumab in people with Neoplasms, run by Boehringer Ingelheim at 48 sites in 15 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
BI 765179, Ezabenlimab and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
48 sitesin 15 countries
Study dates
18 Oct 2021to 17 Feb 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 37Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

48 sites in 15 countries.

48 sites in 15 countries

United States5 sites

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • NEXT Oncology-San Antonio-65273

    San Antonio, Texas, 78229

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • University of Arizona

    Tucson, Arizona, 85719

Other trials in United States

China5 sites

  • The First Affiliated Hospital Of Bengbu Medical College

    Bengbu, 233004

  • Hunan Province Tumor Hospital

    Changsha, 410013

  • Fujian Cancer Hospital

    Fuzhou, 350014

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, 510095

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

    Wuhan, 430022

Other trials in China

Japan5 sites

  • Aichi Cancer Center Hospital

    Aichi, Nagoya, 464-8681

  • National Cancer Center Hospital East

    Chiba, Kashiwa, 277-8577

  • Kanagawa Cancer Center

    Kanagawa, Yokohama, 241-8515

  • Kansai Medical University Hospital

    Osaka, Hirakata, 573-1191

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

Other trials in Japan

Australia4 sites

  • Border Cancer Hospital

    Albury, New South Wales, 2640

  • Kinghorn Cancer Centre

    Darlinghurst, New South Wales, 2010

  • Townsville Hospital

    Douglas, Queensland, 4814

  • Austin Hospital

    Heidelberg, Victoria, 3084

Other trials in Australia

Mexico4 sites

  • Instituto Nacional de Cancerologia

    México, 14080

  • Centro Oncologico Internacional

    Mexico City, 04700

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

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

    Monterrey, 66278

Other trials in Mexico

Spain4 sites

  • Hospital Germans Trias i Pujol

    Badalona, 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Clínica Universidad de Navarra

    Pamplona, 31008

Other trials in Spain

Belgium3 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • AZ Groeninge

    Kortrijk, 8500

Other trials in Belgium

Brazil3 sites

  • ICESP - Instituto do Cancer do Estado de Sao Paulo

    São Paulo, 01246-000

  • Hospital Sírio Libanês-São Paulo-68088

    São Paulo, 01308050

  • Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, 01321-001

Other trials in Brazil

France3 sites

  • HOP Saint-André

    Bordeaux, 33075

  • CTR Georges-François Leclerc

    Dijon, 21079

  • INS Cancérologie Ouest Saint-Herblain

    Saint-Herblain, 44805

Other trials in France

Germany3 sites

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Martin-Luther-Universität Halle-Wittenberg

    Halle, 06120

  • Klinikum Stuttgart

    Stuttgart, 70174

Other trials in Germany

South Korea3 sites

  • Gachon University Gil Medical Center

    Incheon, 21565

  • CHA Bundang Medical Center

    Seongnam, 13496

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Israel2 sites

  • Shaare-Zedek Medical Center, Oncology Institute

    Jerusalem, 9103102

  • Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Netherlands2 sites

  • VU University Medical Center

    Amsterdam, 1081HV

  • Erasmus Medisch Centrum-ROTTERDAM-50697

    Rotterdam, 3015 GD

Other trials in Netherlands

Czechia1 site

  • Masaryk Memorial Cancer Institute

    Brno, 65653

Other trials in Czechia

Italy1 site

  • Istituto Nazionale IRCCS Tumori Fondazione Pascale

    Naples, 80131

Other trials in Italy

About this study

Official title: 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)

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.

Read more

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
Neoplasms
Being tested
BI 765179, Ezabenlimab, Pembrolizumab
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BI 765179Drug

    BI 765179

  • EzabenlimabDrug

    Ezabenlimab

  • PembrolizumabDrug

    Pembrolizumab

Study groups in NCT04958239
Study groupRoleWhat they receive
Phase 1 Arm A: BI 765179ExperimentalNot described
Receives: Drug: BI 765179
Phase 1a Arm B: BI 765179 + ezabenlimabExperimentalNot described
Receives: Drug: BI 765179; Drug: Ezabenlimab
Phase 1b Cohort 1: pembrolizumab + low dose of BI 765179ExperimentalNot described
Receives: Drug: BI 765179; Drug: Pembrolizumab
Phase 1b Cohort 2: pembrolizumab + high dose of BI 765179ExperimentalNot described
Receives: Drug: BI 765179; Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1a: Maximum Tolerated Dose (MTD)

    MTD is defined as the highest dose with less than 25% risk of the true Dose Limiting Toxicity (DLT) rate being equal to or above 33% during the MTD evaluation period. The MTD will be assessed based on the number of patients experiencing DLTs, graded according to Common terminology criteria for adverse events (CTCAE) version 5.0, during the MTD evaluation period.

    Measured: Up to Day 21 (end of Cycle 1)

  2. Phase 1a: Occurrence of Dose Limiting Toxicities (DLTs) in the MTD evaluation period

    Measured: Up to Day 21 (end of Cycle 1)

  3. Phase 1b: Objective response (OR)

    OR is defined as a best overall response of confirmed complete response (CR) or confirmed partial response (PR) according to Response evaluation criteria in solid tumors (RECIST) version (v) 1.1 by Investigator assessment from the date of treatment start until the earliest date of disease progression, death, or last evaluable tumor assessment before start of subsequent anti-cancer therapy, loss to follow-up, or withdrawal of consent.

    Measured: Up to 2 years.

Secondary outcomes (13)

  1. Phase 1a: Occurrence of DLTs during the on-treatment period (per arm)

    Measured: up to 36 months

  2. Phase 1a: Maximum measured concentration of BI 765179 in plasma (Cmax)

    Measured: Up to Day 21 (end of Cycle 1)

  3. Phase 1a: Area under the concentration-time curve of BI 765179 in plasma over a uniform dosing interval from zero to 504h (AUC0-504)

    Measured: Up to Day 21 (end of Cycle 1)

  4. Phase Ib: Occurrence of adverse events (AEs) using the US National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5

    Measured: Up to 2 years.

  5. Phase 1b: Occurrence of serious AEs (SAEs) during the on-treatment period

    Measured: Up to 2 years.

  6. Phase 1b: OR assessed by the Investigator according to immune-related RECIST (iRECIST)

    OR assessed by the Investigator according to immuno-related RECIST (iRECIST) is defined as best overall response of immune-related complete response (iCR) and immune related partial response (iPR), where the best overall response is the best time point response recorded from the first administration of study medication until the end of treatment.

    Measured: Up to 2 years.

  7. Phase Ib: Duration of response (DoR) assessed by RECIST v1.1

    DoR assessed by RECIST v1.1 is defined as the time from first documented CR or PR until the earliest of PD or death among patients with an OR.

    Measured: Up to 2 years.

  8. Phase 1b: DoR assessed by iRECIST

    DoR assessed by iRECIST is defined as the time from first documented iCR or iPR until the earliest of unconfirmed progression of disease (iUPD) or death among patients with an OR (iCR, iPR).

    Measured: Up to 2 years.

  9. Phase 1b: Progression-free survival (PFS) in all patients assessed by the Investigator according to RECIST v1.1

    PFS in all patients assessed by the Investigator according to RECIST v1.1 is defined as the time from first treatment administration until tumor progression or death from any cause, whichever occurs earlier.

    Measured: Up to 2 years.

  10. Phase 1b: PFS in all patients assessed by the Investigator according to iRECIST

    PFS in all patients assessed by the Investigator according to iRECIST is defined as the time from first administration of study medication until the first date of iUPD (provided that confirmed progressive disease (iCPD) is the next time point response, i.e., progression is confirmed at the next tumor assessment) or death from any cause, whichever occurs earlier.

    Measured: Up to 2 years.

  11. Phase 1b: PFS rate at 14 weeks

    PFS rate at 14 weeks is defined as the proportion of patients who survive and are progression free at least 14 weeks after the date of first treatment.

    Measured: Up to 2 years.

  12. Phase 1b: Overall survival (OS)

    OS is defined as the time from first treatment administration until death from any cause.

    Measured: Up to 2 years.

  13. Phase 1b: OS rate at 12 months

    OS rate at 12 months is defined as the proportion of patients with OS ≥12 months after the date of first treatment.

    Measured: Up to 2 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2021
  2. Study start18 Oct 2021
  3. Primary completion27 Apr 2026
  4. Study completion17 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04958239
Sponsor's protocol ID
1463-0001
Other IDs
2021-000234-34, 2023-510307-22-00, U1111-1310-6376, 2023
Status last verified
Oct 2026
First submitted
1 Jul 2021
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 765179, Ezabenlimab and Pembrolizumab in people with Neoplasms, run by Boehringer Ingelheim at 48 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 37 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in United States, China, Japan, Australia, Mexico and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Maximum Tolerated Dose (MTD) (time frame: Up to Day 21 (end of Cycle 1)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04958239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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