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

NCT04958239 | Active Not Recruiting Phase 1 FDA Drug

• 4 other identifiers: 1463-00012021-000234-342023-510307-22-00U1111-1310-6376
• Study Type: interventional
• Target: 151
• Locations: 15 countries
• Sites: 48

Brief 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 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.

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to Day 21 (end of Cycle 1)

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

  Up to Day 21 (end of Cycle 1)

• 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.

  Up to 2 years.

Secondary Outcomes (13)

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

  up to 36 months

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

  Up to Day 21 (end of Cycle 1)

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

  Up to Day 21 (end of Cycle 1)

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

  Up to 2 years.

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

  Up to 2 years.

Study Arms (4)

Phase 1 Arm A: BI 765179

EXPERIMENTAL

Drug: BI 765179

Phase 1a Arm B: BI 765179 + ezabenlimab

EXPERIMENTAL

Drug: BI 765179; Drug: Ezabenlimab

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

EXPERIMENTAL

Drug: BI 765179; Drug: Pembrolizumab

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

EXPERIMENTAL

Drug: BI 765179; Drug: Pembrolizumab

Interventions

Pembrolizumab DRUG

Pembrolizumab

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

BI 765179 DRUG

BI 765179

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

Ezabenlimab DRUG

Ezabenlimab

Phase 1a Arm B: BI 765179 + ezabenlimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (48)

University of Arizona

Tucson, Arizona, 85719, United States

Location

Beverly Hills Cancer Center

Beverly Hills, California, 90211, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

NEXT Oncology-San Antonio-65273

San Antonio, Texas, 78229, United States

Location

Border Cancer Hospital

Albury, New South Wales, 2640, Australia

Location

Kinghorn Cancer Centre

Darlinghurst, New South Wales, 2010, Australia

Location

Townsville Hospital

Douglas, Queensland, 4814, Australia

Location

Austin Hospital

Heidelberg, Victoria, 3084, Australia

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Edegem - UNIV UZ Antwerpen

Edegem, 2650, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

ICESP - Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246-000, Brazil

Location

Hospital Sírio Libanês-São Paulo-68088

São Paulo, 01308050, Brazil

Location

Beneficência Portuguesa - Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, 01321-001, Brazil

Location

The First Affiliated Hospital Of Bengbu Medical College

Bengbu, 233004, China

Location

Hunan Province Tumor Hospital

Changsha, 410013, China

Location

Fujian Cancer Hospital

Fuzhou, 350014, China

Location

Affiliated Cancer Hospital and Institute of Guangzhou Medical University

Guangzhou, 510095, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

Location

HOP Saint-André

Bordeaux, 33075, France

Location

CTR Georges-François Leclerc

Dijon, 21079, France

Location

INS Cancérologie Ouest Saint-Herblain

Saint-Herblain, 44805, France

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Martin-Luther-Universität Halle-Wittenberg

Halle, 06120, Germany

Location

Klinikum Stuttgart

Stuttgart, 70174, Germany

Location

Shaare-Zedek Medical Center, Oncology Institute

Jerusalem, 9103102, Israel

Location

Sourasky Medical Center

Tel Aviv, 6423906, Israel

Location

Istituto Nazionale IRCCS Tumori Fondazione Pascale

Naples, 80131, Italy

Location

Aichi Cancer Center Hospital

Aichi, Nagoya, 464-8681, Japan

Location

National Cancer Center Hospital East

Chiba, Kashiwa, 277-8577, Japan

Location

Kanagawa Cancer Center

Kanagawa, Yokohama, 241-8515, Japan

Location

Kansai Medical University Hospital

Osaka, Hirakata, 573-1191, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Centro Oncologico Internacional

Mexico City, 04700, Mexico

Location

Instituto Nacional de Cancerologia

México, 14080, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

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

Monterrey, 66278, Mexico

Location

VU University Medical Center

Amsterdam, 1081HV, Netherlands

Location

Erasmus Medisch Centrum-ROTTERDAM-50697

Rotterdam, 3015 GD, Netherlands

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

CHA Bundang Medical Center

Seongnam, 13496, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Hospital Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Related Links

• Related Info

MeSH Terms

Conditions

Neoplasms

Interventions

pembrolizumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 12, 2021
• Study Start: October 18, 2021
• Primary Completion: April 27, 2026
• Study Completion (Estimated): February 17, 2028
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3); ES (4); DE (3); IL (2); US (5); CN (5); JP (5); ME (4); NL (2); CZ (1); FR (3); BE (3); BR (3); AU (4); IT (1)