A Study to Test Whether Different Combinations of BI 765063, Ezabenlimab, Chemotherapy, Cetuximab, and BI 836880 Help People With Head and Neck Cancer or Liver Cancer

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

April 12, 2022

Primary Completion Date

July 15, 2024

Study Completion Date

July 31, 2026

Conditions
Head and Neck Squamous Cell Carcinoma (HNSCC)
Interventions
DRUG

BI 765063

BI 765063 (anti-Signal Regulatory Protein Alpha (SIRPα) Monoclonal Antibody (mAb))

DRUG

Ezabenlimab

Ezabenlimab (anti-Programmed cell death protein 1 (PD-1) Monoclonal Antibody (mAb))

DRUG

BI 836880

BI 836880 (anti-Vascular Endothelial Growth Factor (VEGF) / Angiopoetin 2 (Ang2))

DRUG

Cetuximab

Cetuximab

OTHER

Investigator´s Choice Chemotherapy

Allowable chemotherapies include: paclitaxel, docetaxel, capecitabine, 5-fluorouracil, methotrexate or combinations thereof

Trial Locations (25)

10330

King Chulalongkorn Memorial Hospital, Bangkok

13385

HOP Timone, Marseille

21079

CTR Georges-François Leclerc, Dijon

28040

Hospital Clínico San Carlos, Madrid

31059

INS Claudius Regaud IUCT-Oncopole, Toulouse

45070

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

67091

HOP Civil, Strasbourg

69373

CTR Leon Berard, Lyon

75248

INS Curie, Paris

81100

Hospital Sultan Ismail, Johor Bahru

90067

Valkyrie Clinical Trials, Los Angeles

90110

Songklanagarind Hospital, Songkhla

91900

FAICIC S de RL de C.V., Veracruz

93586

Sarawak General Hospital, Kuching, Sarawak

400015

"Institutul Oncologic Prof. Dr. Ion Chiricuta", Cluj-Napoca

135-8550

Japanese Foundation for Cancer Research, Tokyo, Koto-ku

06700

ARKE SMO S.A. de C.V, Mexico City

MD-2025

ARENSIA Exploratory Medicine, Chisinau

20-093

Mandziuk Slawomir Specialist Medical Practice, Lublin

022328

"Prof. Dr. Alexandru Trestioreanu Oncology Institut", Bucharest

08035

Hospital Vall d'Hebron, Barcelona

08907

Hospital Duran i Reynals, L'Hospitalet de Llobregat

SE5 9RS

King's College Hospital, London

SW3 6JJ

The Royal Marsden Hospital, Chelsea, London

W12 0HS

Hammersmith Hospital, London

Sponsors
All Listed Sponsors
lead

Boehringer Ingelheim

INDUSTRY