BI 765049 / Boehringer Ingelheim, Oxford BioTherapeutics - LARVOL DELTA

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=97 | Recruiting | Sponsor: Boehringer Ingelheim | N=70 ➔ 97

Enrollment change • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas (clinicaltrials.gov) - P1 | N=135 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Colon Cancer • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Rectal Cancer • Solid Tumor

Determining the Maximum Tolerated Dose of BI 765049 in Colorectal, Gastric, and Pancreatic Cancers: A Phase I Trial [WITHDRAWN] (ESMO 2025) - No abstract available

P1 data • Oncology • Pancreatic Cancer • Solid Tumor

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2027 ➔ Sep 2028 | Trial primary completion date: Sep 2027 ➔ Jun 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Feb 2027 ➔ Dec 2027 | Trial primary completion date: Nov 2026 ➔ Sep 2027

Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas (clinicaltrials.gov) - P1 | N=135 | Recruiting | Sponsor: Boehringer Ingelheim | N=100 ➔ 135

Enrollment change • Colon Cancer • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Rectal Cancer • Solid Tumor

A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Colon Cancer • Colorectal Cancer • Gastric Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Rectal Cancer • Solid Tumor

A Study to Test Different Doses of BI 765049 in People With Advanced Cancer of the Colon, Rectum, Stomach, or Pancreas (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Boehringer Ingelheim

New P1 trial • Colon Cancer • Colorectal Cancer • Gastric Cancer • Hepatology • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Rectal Cancer • Solid Tumor

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface (clinicaltrials.gov) - P1 | N=67 | Completed | Sponsor: Boehringer Ingelheim | Active, not recruiting ➔ Completed | Trial completion date: Dec 2028 ➔ Nov 2024 | Trial primary completion date: Dec 2025 ➔ Nov 2024

Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface (clinicaltrials.gov) - P1 | N=67 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | N=248 ➔ 67

Enrollment change • Enrollment closed • Metastases • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Expressing the Protein B7-H6 on the Cell Surface (clinicaltrials.gov) - P1 | N=248 | Recruiting | Sponsor: Boehringer Ingelheim | N=120 ➔ 248

Enrollment change • Metastases • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A phase Ia/Ib, non-randomized, open-label, dose escalation and expansion trial of the B7-H6/CD3 T-cell engager BI 765049 with or without ezabenlimab in Asian patients with advanced solid tumors. (ASCO 2024) - P1 | "Zhang W, et al. Clin Cancer Res 2022; 28(23):5190–5201."

Clinical • IO biomarker • Metastases • P1 data • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: May 2025 ➔ Dec 2028 | Trial primary completion date: May 2025 ➔ Dec 2025

Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Boehringer Ingelheim | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Nov 2023 ➔ May 2025

Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jan 2026 ➔ Mar 2027 | Trial primary completion date: Nov 2025 ➔ Dec 2026

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Boehringer Ingelheim | Initiation date: Oct 2023 ➔ Feb 2024

Combination therapy • Metastases • Trial initiation date • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study to Test Different Doses of BI 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=70 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Combination therapy • Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatology • Liver Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • NCR3LG1

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2024 ➔ May 2025

Metastases • Trial completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With Ezabenlimab to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Feb 2023 ➔ Nov 2023

Metastases • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1

A first-in-human phase I dose-escalation trial of the B7-H6/CD3 T-cell engager BI 765049 ± ezabenlimab (BI 754091) in patients with advanced solid tumors expressing B7-H6 (SITC 2021) - P1 | "As of July 2021, patients are being recruited in early dose-escalation cohorts. Trial Registration NCT04752215"

Clinical • IO biomarker • P1 data • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A first-in-human phase I dose-escalation trial of the B7-H6/CD3 T-cell engager BI 765049 ± ezabenlimab (BI 754091) in patients with advanced solid tumors expressing B7-H6. (ASCO 2022) - P1 | "Approximately 150–175 patients will be screened and ̃120 patients enrolled. As of January 2022, eight patients have been recruited in early dose-escalation cohorts."

Clinical • IO biomarker • P1 data • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • NCR3LG1 • PD-L1

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With BI 754091 to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov) - P1; N=120; Recruiting; Sponsor: Boehringer Ingelheim; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With BI 754091 to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov) - P1; N=120; Not yet recruiting; Sponsor: Boehringer Ingelheim; Initiation date: Feb 2021 ➔ Jul 2021

Clinical • Trial initiation date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

A Study Evaluating Different Doses of BI 765049 When Given Alone and When Given With BI 754091 to Patients With Advanced Solid Tumors Having the B7-H6 Marker (clinicaltrials.gov) - P1; N=120; Not yet recruiting; Sponsor: Boehringer Ingelheim; Trial completion date: Sep 2024 ➔ Dec 2024; Trial primary completion date: Oct 2023 ➔ Feb 2023

Clinical • Trial completion date • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Head and Neck Cancer • Hepatocellular Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck