BI 765049 / Boehringer Ingelheim, Oxford BioTherap - LARVOL DELTA

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Determining the Maximum Tolerated Dose of BI 765049 in Colorectal, Gastric, and Pancreatic Cancers: A Phase I Trial [WITHDRAWN] (ESMO 2025) - No abstract available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

Boehringer Ingelheim and Oxford BioTherapeutics Partnership Advances Second Oncology Drug Candidate into the Clinic (PRNewswire) - "Oxford BioTherapeutics...announced that it has received another milestone payment from Boehringer Ingelheim (BI) for the progress of a second oncology drug candidate (BI 765049), discovered during the first phase of the partnership, into the clinic. In addition to OBT's clinical asset, OBT076, this BI drug candidate is one of OBT's several existing immuno-oncology programs that have been enabled through OGAP®. In this Phase 1 clinical trial, BI 765049, will be administered to patients with advanced solid tumours including colorectal cancer, gastric carcinoma, pancreatic carcinoma, non-small cell lung cancer, hepatocellular carcinoma, and head and neck squamous cell carcinoma."

Licensing / partnership • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Hepatocellular Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck