BI 765179 / Boehringer Ingelheim - LARVOL DELTA

An open-label, phase Ib dose-expansion study to assess the efficacy of CD137/FAP agonist BI 765179 plus pembrolizumab as a first-line treatment in metastatic or incurable, recurrent programmed cell death ligand-1 (PD-L1)-positive head and neck squamous cell carcinoma (HNSCC). (ASCO 2025) - P1 | "Secondary endpoints include occurrence of adverse events (AEs) and serious AEs, OR (immune-related RECIST v1.1), duration of response, progression-free survival, and overall survival. Reused with permission."

Clinical • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • FAP • PD-L1 • TNFRSF9

An open-label, phase Ib dose-expansion study to assess the efficacy of CD137/FAP agonist BI 765179 plus pembrolizumab as a first-line treatment in metastatic or incurable, recurrent programmed cell death ligand-1 (PD-L1)-positive, head and neck squamous cell carcinoma (HNSCC) (AACR 2025) - P1 | "The primary endpoint is objective response (OR), defined as best overall response of confirmed complete response or confirmed partial response (RECIST v1.1). Secondary endpoints include OR (immune-related RECIST), occurrence of adverse events (AEs) and serious AEs, duration of response, progression-free survival, and overall survival."

Clinical • Metastases • P1 data • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • FAP • PD-L1 • TNFRSF9

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 (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Aug 2027 ➔ Jan 2027

Trial primary completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

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 (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jan 2027 ➔ Nov 2028 | Trial primary completion date: Apr 2026 ➔ Aug 2027

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Mar 2026 ➔ Nov 2026 | Trial primary completion date: Jun 2025 ➔ Feb 2026

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Boehringer Ingelheim | Suspended ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • FAP

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=160 | Suspended | Sponsor: Boehringer Ingelheim | Recruiting ➔ Suspended

Combination therapy • Metastases • Monotherapy • Trial suspension • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • FAP

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=160 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jul 2025 ➔ May 2026 | Trial primary completion date: Sep 2024 ➔ Jul 2025

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • FAP

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jan 2025 ➔ Jul 2025 | Trial primary completion date: Mar 2024 ➔ Sep 2024

Combination therapy • Monotherapy • Trial completion date • Trial primary completion date • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • FAP

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1; N=150; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Combination therapy • Enrollment open • Monotherapy • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • FAP

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors) (clinicaltrials.gov) - P1; N=150; Not yet recruiting; Sponsor: Boehringer Ingelheim

Clinical • Combination therapy • Monotherapy • New P1 trial • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastrointestinal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • FAP