ezabenlimab (BI 754091) / Boehringer Ingelheim - LARVOL DELTA

Efficacy and safety of the MDM2–p53 antagonist BI 907828 in patients with advanced biliary tract cancer: Data from two phase Ia/Ib dose-escalation/expansion trials. (ASCO-GI 2023) - P1a/1b, P2a/2b | "Patients in the combination trial received escalating doses of BI 907828 and 240 mg ezabenlimab q3w (doublet); one patient also received the anti-LAG-3 antibody BI 754111 (a drug that has since been discontinued; triplet). The MDM2–p53 antagonist BI 907828 has shown a manageable safety profile and encouraging preliminary efficacy in patients with BTC, with 5 PRs and 2 SD in 8 patients. A phase IIa/IIb trial of BI 907828 (45 mg q3w) in patients with BTC is planned to start recruitment at the end of 2022 (NCT05512377). Clinical trial information: NCT03449381 and NCT03964233."

Clinical • IO biomarker • Metastases • P1 data • Ampulla of Vater Carcinoma • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MDM2 • TP53

A phase I dose escalation trial of obrixtamig + ezabenlimab in patients (pts) with small cell lung cancer (SCLC) or other neuroendocrine carcinomas (NECs) expressing DLL3 (ELCC 2026) - P1 | "Legal entity responsible for the study Boehringer Ingelheim. Funding Boehringer Ingelheim."

Clinical • P1 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

Local CAR-NK cell therapy combined with PD-1 blockade induces immune remodeling in recurrent glioblastoma (EANO 2026) - "In immunocompetent mouse models, locally delivered chimeric antigen receptor-engineered natural killer (CAR-NK) cell therapy results in rejection of experimental gliomas dependent on adaptive immunity.Material and We conducted a first-in-human phase I trial of repetitive intracranial administration of irradiated HER2-targeted CAR-NK cells derived from the human NK-92 cell line, administered alone (n=6) or combined with systemic PD-1 blockade with ezabenlimab (n=12), in patients with recurrent HER2-positive glioblastoma. Repetitive local CAR-NK cell delivery alone or in combination with systemic immune checkpoint blockade was feasible and well tolerated... These findings suggest that the promotion of an endogenous adaptive immune response may be a novel and clinically relevant component of CAR-NK cell and checkpoint inhibitor combination immunotherapy for glioblastoma."

First-in-human • Brain Cancer • Glioblastoma • Oncology • Solid Tumor • HER-2

Updated Phase Ia results with systemic STING agonist BI 1703880 plus ezabenlimab in patients (pts) with advanced solid tumors (ESMO 2026) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor

Phase I, non-randomised, open-label, multi-centre dose escalation trial of BI 764532 (DLL3/CD3 IgG-like T cell engager [TcE]) + ezabenlimab (anti-PD-1 antibody) in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs) expressing DLL3 (ESMO 2023) - P1 | "In the dose escalation part, the primary endpoint is dose-limiting toxicity (DLT) occurrence in the MTD evaluation period; secondary endpoints include DLT occurrence in the on-treatment period, objective response and pharmacokinetics. Enrolment is ongoing."

Clinical • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

A Study to Test How BI 765063 and BI 770371 Are Taken up in Tumours of People With Different Types of Advanced Cancer Who Are Also Taking Ezabenlimab (clinicaltrials.gov) - P1 | N=14 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Sep 2026 ➔ Jul 2027 | Trial primary completion date: Sep 2026 ➔ Jan 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • SIRPA

A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlimab Are Tolerated in People With Different Types of Advanced Cancer (Solid Tumours) (clinicaltrials.gov) - P1 | N=66 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Sep 2028 ➔ Jan 2029

First-in-human • Trial completion date • Oncology • Solid Tumor

A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2026 ➔ Mar 2027

Trial completion date • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

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 765049 Alone and in Combination With Ezabenlimab in Asian People With Advanced Cancer (Solid Tumours) Positive for B7-H6 (clinicaltrials.gov) - P1 | N=21 | Terminated | Sponsor: Boehringer Ingelheim | Trial completion date: Oct 2025 ➔ Feb 2026 | Completed ➔ Terminated; Sponsor decision

Trial completion date • Trial termination • 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 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 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: Nov 2028 ➔ May 2028 | Trial primary completion date: Jan 2027 ➔ Jul 2026

Monotherapy • Trial completion date • 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=149 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting | Trial completion date: May 2028 ➔ Feb 2028

Enrollment closed • Monotherapy • Trial 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 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=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=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 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=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

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 in People With Advanced Cancer to Test How Well Different Doses of BI 770371 Alone or in Combination With Ezabenlimab Are Tolerated (clinicaltrials.gov) - P1 | N=42 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Sep 2026 ➔ Mar 2027

Trial completion date • Oncology • Solid Tumor

KISIMA-02: A Study to Evaluate ATP150/ATP152/ATP162, VSV-GP154 and Ezabenlimab in Patients With Pancreatic Ductal Adenocarcinoma (clinicaltrials.gov) - P1 | N=59 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Aug 2027 ➔ Mar 2027

Trial completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • KRAS

A Study to Test KISIMA-02 Vaccine-based Immunotherapy and Ezabenlimab in People With Pancreatic Cancer (clinicaltrials.gov) - P1 | N=58 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Mar 2027 ➔ Aug 2027

Trial completion date • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • KRAS

A Study to Evaluate ATP150/ATP152, VSV-GP154 and Ezabenlimab in Patients With KRAS G12D/G12V Mutated PDAC (KISIMA-02) (clinicaltrials.gov) - P1 | N=85 | Recruiting | Sponsor: Amal Therapeutics | Phase classification: P1b ➔ P1

Phase classification • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • KRAS