Open-label, phase Ia study of STING agonist BI 1703880 plus ezabenlimab for patients with advanced solid tumors
Por:
Harrington K, Kitano S, Gambardella V, Parkes E, Moreno I, Alonso G, Doi T, Berz D, Gutierrez M, Fernandez N, Schmohl M, Barrueco J, Lorusso P
Publicada:
14 ene 2025
Ahead of Print:
1 ene 2025
Resumen:
BI 1703880, a novel STimulator of INterferon Genes (STING) agonist, has demonstrated preclinical antitumor activity. As STING activation can upregulate programmed death ligand 1 and human leukocyte antigen in tumor cells, a combination of BI 1703880 and an anti-programmed cell death protein 1-antibody, such as ezabenlimab, may improve efficacy. This first-in-human phase Ia study (NCT05471856) is evaluating BI 1703880 plus ezabenlimab in patients with advanced solid tumors. The study utilizes an innovative lead-in design; all patients receive BI 1703880 monotherapy in Cycle 1 and combination therapy from Cycle 2. 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
There are many different types of treatments available for patients with cancer. One type of treatment aims to use the patient's own immune system to target and destroy the cancer, known as immunotherapy. BI 1703880 is a new drug that has been developed to activate the immune system for the treatment of cancer. This study is evaluating BI 1703880 for patients with advanced cancers based on its ability to destroy cancer cells in animal studies. BI 1703880 is being investigated on its own and in combination with another drug, ezabenlimab. The reason for testing these two drugs together is because sometimes cancer cells can become resistant to one type of immunotherapy, making proteins to "turn off" the immune response targeting the cancer. Similar to BI 1703880, ezabenlimab is also an immunotherapy. However, it turns the immune system on in a different way from BI 1703880, which means they may work together to produce a better anticancer result. The objective of the study is to determine a suitable dose of BI 1703880 alone and in combination with ezabenlimab and to see if any side effects occur.
Filiaciones:
Harrington K:
Royal Marsden NHS Fdn Trust, Inst Canc Res, Fulham Rd, London SW3 6JB, England
Kitano S:
Japanese Fdn Canc Res, Tokyo, Japan
Gambardella V:
Hosp Clin Valencia, INCLIVA Biomed Res Inst, Valencia, Spain
Parkes E:
Univ Oxford, Churchill Hosp, Dept Oncol, Oxford, England
Moreno I:
START Madrid, Ctr Integral Oncol Clara Campal, CIOCC, Madrid, Spain
Alonso G:
Hosp Valle De Hebron, Barcelona, Spain
Doi T:
Natl Canc Ctr Hosp East, Chiba, Japan
Berz D:
Valkyrie Clin Trials, Los Angeles, CA USA
Gutierrez M:
John Theurer Canc Ctr, Hackensack, NJ USA
Fernandez N:
Boehringer Ingelheim Espana S A, Sant Cugat Del Valles, Barcelona, Spain
Schmohl M:
Boehringer Ingelheim Int GmbH, Ingelheim, Germany
Barrueco J:
Boehringer Ingelheim Pharmaceut Inc, Ridgefield, CT USA
Lorusso P:
Yale Univ, Sch Med, New Haven, CT USA
Ctr Integral Oncol Clara Campal, START Madrid, CIOCC, Madrid, Spain
Boehringer Ingelheim Espana SA, Barcelona, Spain
Green Accepted
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