HARMONi Clinical Trial
HARMONi Phase 3 Clinical Trial
EGFR+ Advanced NSCLC Who Have Progressed After 3rd Generation EGFR-TKI (osimertinib)
NCT05184712: Click to view on ClinicalTrials.gov
Ivonescimab: Most Advanced PD-1/VEGF Bispecific Antibody in Clinical Development in the U.S. & EU.*
Brings two validated mechanisms in oncology1,2,3 into ONE novel tetravalent molecule.
Ivonescimab simultaneously engages both PD-1 & VEGF.
To-date 825+ patients have been treated with ivonescimab in clinical trials in China and Australia. Summit is actively recruiting 100+ patients in the U.S., Canada and Europe; the overall study will include over 400 patients worldwide.
KEY ELIGIBILITY CRITERIA
- Expected survival ≥3 months
- Locally advanced (Stage IIIB/IIIC) or metastatic NSCLC that has progressed on 3rd generation EGFR-TKI (e.g., osimertinib)
- At least 1 measurable noncerebral lesion
- Adequate organ and hematologic function
- Has not received other systemic antitumor therapy for the advanced stage (IIIB to IV) of NSCLC
- Tumor does not surround important blood vessels, have obvious necrosis and/or cavitation or invade the surrounding vital organs and blood vessels
- No symptomatic metastases of the central nervous system
- No history of esophageal gastric varices, severe ulcers or wounds that do not heal
- No history of severe bleeding tendencies or coagulopathy, or hemoptysis within last 4 weeks
For additional information on the HARMONi Clinical Trial, please contact email@example.com
1. Manegold et al., (2016); JTO 12:2.194-207.; 2. Pardoll, Drew M. (2012) Nature Reviews Cancer vol. 12,4 :252-64.; 3. Tamura et al., (2020) Med Oncol 37:2, 10.1007.