ezabenlimab (BI 754091) / Boehringer Ingelheim - LARVOL DELTA

Ezabenlimab (BI 754091) and induction mDCF (modified docetaxel, cisplatin, and 5-fluorouracil) followed by adaptive chemoradiotherapy in patients (pts) with stage III squamous cell anal carcinoma (SCAC): final results of the Phase II INTERACT-ION study (ESMO 2025) - No abstract available

Clinical • P2 data • Anal Carcinoma • Oncology • Solid Tumor

Phase Ia results for systemic STING agonist BI 1703880 plus ezabenlimab in patients (pts) with advanced solid tumors: Progress to date (ESMO 2025) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor

A Trial of BI 765063 Monotherapy and in Combination With BI 754091 in Patients With Advanced Solid Tumours (clinicaltrials.gov) - P1 | N=100 | Completed | Sponsor: OSE Immunotherapeutics | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Apr 2025

Trial completion • Trial completion date • Colorectal Cancer • Endometrial Cancer • Solid Tumor • SIRPA

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

An open-label, phase I trial of the SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab in patients with advanced solid tumors. (ASCO 2025) - P1 | "No DLTs were reported during the MTD evaluation period with BI 770371 monotherapy or with the combination; 1 pt in the monotherapy group had a DLT (grade 2 encephalitis, which resolved within 1 week) during the on-treatment period (likely due to prior nivolumab and ipilimumab treatment). These preliminary data indicate that BI 770371 is well tolerated alone and in combination with ezabenlimab, with promising antitumor activity seen in heavily pretreated pts with advanced solid tumors. The MTD of BI 770371 was not reached in either group."

Clinical • Combination therapy • Metastases • P1 data • CNS Disorders • Dermatology • Fatigue • Oncology • Pruritus • Solid Tumor • SIRPA

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=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2026 ➔ Dec 2025

Trial 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 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=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Sep 2025 ➔ Sep 2026

Trial completion date • Oncology • Solid Tumor

Boehringer Ingelheim to present early clinical evidence of innate immune modulation and anti-tumor activity via SIRPα blockade in two ongoing trials at ASCO 2025 (GlobeNewswire) - P1b | N=48 | NCT05249426 | P1 | N=36 | NCT05327946 | Sponsor: Boehringer Ingelheim | "In a Phase 1b study conducted by Boehringer, its potential, first-in-class SIRPα monoclonal antibody, BI 765063, demonstrated a manageable safety profile as well as preliminary signs of immune activation and additive antitumor activity when combined with PD-1 inhibitor ezabenlimab and cetuximab in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Additionally, in an open-label, Phase I trial conducted by Boehringer, its next-generation SIRPα monoclonal antibody, BI 770371, alone and in combination with the PD-1 inhibitor ezabenlimab, was shown to be well tolerated in patients with advanced solid tumors. There were no dose-limiting toxicities in either treatment arm, and the maximum tolerated dose was not reached in either group."

P1 data • Squamous Cell Carcinoma of Head and Neck

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=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial primary completion date: Jun 2025 ➔ Oct 2025

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 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=13 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Oct 2025 ➔ Dec 2026

Trial 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 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=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jun 2026 ➔ Sep 2025

Trial completion date • 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 | 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 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) - P1/2 | N=45 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Small Cell Lung Cancer • Solid Tumor • DLL3

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 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

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: May 2027 ➔ Sep 2028 | Trial primary completion date: Mar 2027 ➔ Sep 2028

Trial completion date • Trial primary completion date • Oncology • Solid Tumor

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=36 | Active, not recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Mar 2025 ➔ Jun 2026

Trial completion date • Oncology • Solid Tumor

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 primary completion date: Jan 2025 ➔ Mar 2027

Trial primary 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) - P1/2 | N=43 | Recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Jun 2025 ➔ Sep 2025 | Trial primary completion date: Jun 2025 ➔ Sep 2025

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

KISIMA-01: Phase 1b Study to Evaluate ATP128, VSV-GP128 and BI 754091, in Patients With Stage IV Colorectal Cancer (clinicaltrials.gov) - P1 | N=96 | Active, not recruiting | Sponsor: Amal Therapeutics | Trial completion date: Dec 2024 ➔ Aug 2025 | Trial primary completion date: Jul 2024 ➔ May 2025

Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Cancer • Hepatology • Oncology • Solid Tumor

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

Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors. (PubMed, Future Oncol) - P1 | "The primary endpoint is dose-limiting toxicities during the maximum tolerated dose evaluation period. Results will inform the future development of BI 1703880 for treatment of metastatic or recurrent malignancies.Clinical Trial number: NCT05471856."

Journal • P1 data • Oncology • Solid Tumor • STING

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

INTERACT-ION: Anti-PD-1 and mDCF Followed by Chemoradiotherapy in Patients With Stage III Squamous Cell Anal Carcinoma. (clinicaltrials.gov) - P2 | N=55 | Active, not recruiting | Sponsor: Centre Hospitalier Universitaire de Besancon | Trial primary completion date: Jul 2024 ➔ Nov 2024

Trial primary completion date • Anal Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma

Modulation of the intratumoral immune microenvironment by local therapy with natural killer cells engineered with a HER2-targeted chimeric antigen receptor in combination with systemic anti-PD-1 checkpoint inhibition in patients with recurrent glioblastoma (SNO 2024) - "In the multicenter CAR2BRAIN phase I first-in-human clinical trial, we investigated the modulation of the tumor microenvironment by repetitive local injection of clonal chimeric antigen receptor (CAR)-NK cells (NK-92/5.28.z) targeting HER2 alone and in combination with systemic anti-PD-1 checkpoint inhibitor therapy in patients with recurrent HER2-positive GB. Local immunotherapy with HER2-targeted CAR-NK cells is feasible and safe both as monotherapy and in combination with the systemic checkpoint inhibitor ezabenlimab and induces local immune reactions in CSF and tumor tissue. Given the signal for possible clinical benefit provided by the increase in PFS in the patients of the biopsy-treat-resect-treat cohort, further trials are warranted."

Checkpoint inhibition • Clinical • Combination therapy • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor • CD4 • CD8 • FOXP3 • HER-2