BI 836880 / Boehringer Ingelheim - LARVOL DELTA

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 (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=305; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Dec 2021 ➔ Jul 2023; Trial primary completion date: Aug 2021 ➔ Mar 2023

Clinical • Combination therapy • PD(L)-1 companion diagnostic • Trial completion date • Trial primary completion date • Glioblastoma • Immune Modulation • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MRI • PD-L1

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=80; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • Combination therapy • New P1 trial • PD(L)-1 companion diagnostic • Glioblastoma • Immune Modulation • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • PD-L1

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Oct 2020 ➔ Feb 2021; Trial primary completion date: Oct 2020 ➔ Feb 2021

Clinical • Combination therapy • PD(L)-1 companion diagnostic • Trial completion date • Trial primary completion date • Glioblastoma • Immune Modulation • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • PD-L1

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Feb 2021 ➔ Aug 2021; Trial primary completion date: Feb 2021 ➔ Aug 2021

Clinical • Combination therapy • PD(L)-1 companion diagnostic • Trial completion date • Trial primary completion date • Glioblastoma • Immune Modulation • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=227; Recruiting; Sponsor: Boehringer Ingelheim; N=80 ➔ 227

Clinical • Combination therapy • Enrollment change • PD(L)-1 companion diagnostic • Glioblastoma • Immune Modulation • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=245; Recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Aug 2021 ➔ Dec 2021

Clinical • Combination therapy • PD(L)-1 companion diagnostic • Trial completion date • Glioblastoma • Immune Modulation • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=245; Suspended; Sponsor: Boehringer Ingelheim; Recruiting ➔ Suspended

Clinical • Combination therapy • PD(L)-1 companion diagnostic • Trial suspension • Glioblastoma • Immune Modulation • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

A Study to Test Different Doses of BI 836880 Combined With BI 754091 in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1; N=245; Recruiting; Sponsor: Boehringer Ingelheim; Suspended ➔ Recruiting

Clinical • Combination therapy • Enrollment open • PD(L)-1 companion diagnostic • Glioblastoma • Immune Modulation • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer • PD-L1

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 (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

An open-label, phase Ib trial of the SIRPα inhibitor BI 765063 in combination with the PD-1 inhibitor ezabenlimab and cetuximab in patients (pts) with head and neck squamous cell carcinoma. (ASCO 2025) - P1 | "This Phase Ib study (NCT05249426) is investigating the efficacy and safety of BI 765063 in combination with ezabenlimab + cetuximab (Cohort A) or ezabenlimab + chemotherapy (Cohort B) in pts with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC), or in combination with ezabenlimab ± BI 836880 (anti-VEGF/Ang2) in pts with hepatocellular carcinoma. These preliminary data indicate that BI 765063 in combination with ezabenlimab and cetuximab has a manageable safety profile and promising efficacy as second-line treatment in pts with R/M HNSCC. Biomarker data will be presented at the meeting."

Clinical • Combination therapy • IO biomarker • P1 data • Anemia • Cardiovascular • Congestive Heart Failure • Dermatitis • Dermatology • Endocrine Disorders • Head and Neck Cancer • Heart Failure • Hematological Disorders • Hepatocellular Cancer • Hepatology • Immunology • Liver Failure • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

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 (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Apr 2026 ➔ Jul 2026

Trial completion date • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

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 (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Aug 2025 ➔ Apr 2026

Trial completion date • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours (clinicaltrials.gov) - P2 | N=212 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed | Trial completion date: May 2025 ➔ Dec 2024 | Trial primary completion date: May 2025 ➔ Dec 2024

Trial completion • Trial completion date • Trial primary completion date • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Oncology • Solid Tumor

Comprehensive biomarker and modeling approach to support dose finding for BI 836880, a VEGF/Ang-2 inhibitor. (PubMed, J Transl Med) - P1 | "The comprehensive analyses of multiple target engagement markers support BI 836880 720 mg q3w as a biologically relevant monotherapy dose schedule."

Biomarker • Journal • Oncology • Solid Tumor

Exploring new horizons in neovascular age-related macular degeneration: novel mechanisms of action and future therapeutic avenues. (PubMed, Eye (Lond)) - "Gene therapies, including RGX-314 and Ixo-vec, express an anti-VEGF protein, and 4D-150, expresses an anti-VEGF protein and a VEGF-C inhibitory miRNA. Anti-VEGF associated therapeutics include OPT-302, targeting VEGF-C and VEGF-D, BI 836880, which inhibits VEGF-A and Ang-2 activity, and Tarcocimab tedromer, inhibiting all VEGF-A isoforms. Agents with novel mechanisms of action include UBX1325, which inhibits an anti-apoptotic protein, Restoret (EYE103), a Wnt agonist, and the tyrosine kinase inhibitors, EYP-1901, OTX-TKI, CLS-AX, and KHK4951."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration • VEGFC • VEGFD

A Study to Test Different Doses of BI 836880 Combined With Ezabenlimab in Patients With Advanced Non-small Cell Lung Cancer Followed by Other Types of Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=252 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Glioblastoma • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

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 (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Nov 2024 ➔ Jul 2024

Combination therapy • Metastases • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

Platform Trial Evaluating Safety and Efficacy of BI 754091 Anti- PD-1 Based Combination Therapies in PD-(L)1 naïve and PD- (L)1 Pretreated Patient Populations With Advanced/Metastatic Solid Tumours (clinicaltrials.gov) - P2 | N=212 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jun 2024 ➔ May 2025 | Trial primary completion date: Jun 2024 ➔ May 2025

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Endometrial Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology • Solid Tumor

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 (clinicaltrials.gov) - P1 | N=48 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2025 ➔ Nov 2024

Combination therapy • Enrollment closed • Metastases • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

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 (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Recruiting | Trial primary completion date: Aug 2024 ➔ Apr 2025

Combination therapy • Enrollment open • Metastases • Trial primary completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

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 (clinicaltrials.gov) - P1 | N=47 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Metastases • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

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 (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Boehringer Ingelheim | N=150 ➔ 45

Enrollment change • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD) (clinicaltrials.gov) - P1/2 | N=43 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

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 (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jul 2024 ➔ Jun 2025

Combination therapy • Metastases • Trial completion date • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck