BI 1703880 / Boehringer Ingelheim - LARVOL DELTA

Phase Ia results for systemic STING agonist BI 1703880 plus ezabenlimab in patients (pts) with advanced solid tumors: Progress to date (ESMO 2025) - P1 | "Conclusions The study is ongoing to determine the recommended dose for expansion cohorts. Clinical benefit has been observed, including in IO-pretreated pts, with manageable adverse events."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • CD8

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 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

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

Systemic STING agonist BI 1703880 plus ezabenlimab in patients (pts) with advanced solid tumors: Initial results from a phase Ia study (ESMO 2024) - P1 | "The study is ongoing to evaluate DLTs and determine the recommended expansion dose. Clinical benefit has been observed with manageable safety."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • IFNB1 • IFNG

An intravenously administered STING agonist, BI 1703880, with a novel lead-in design in combination with ezabenlimab (JSMO 2023) - No abstract available

Combination therapy

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 | Not yet recruiting ➔ Recruiting | N=36 ➔ 66

Combination therapy • Enrollment change • Enrollment open • Metastases • Oncology • Solid Tumor

Trial in progress: An intravenously administered second-generation STING agonist, BI 1703880 with a novel lead-in design in combination with ezabenlimab (SITC 2022) - "Peripheral and tumor biomarkers will be analyzed to assess the BI 1703880 mode of action. Peripheral cytokine analysis will supplement clinical safety profiles for informing dose escalation decisions, since cytokine release syndrome is a potential risk for STING agonists."

Combination therapy • IO biomarker • Oncology • Solid Tumor • IFNAR2 • IFNB1 • STING

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=36 | Not yet recruiting | Sponsor: Boehringer Ingelheim | Trial completion date: Dec 2026 ➔ Mar 2027 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Combination therapy • Trial completion date • Trial primary 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=36 | Not yet recruiting | Sponsor: Boehringer Ingelheim

Combination therapy • New P1 trial • Oncology • Solid Tumor