TIGER will undertake a Phase I/IIa open label study to assess the safety, tolerability, immunogenicity and clinical activity EI-201, given intravenously in patients with recurrent or metastatic HPV16+ cancer.
EI-201 is a proprietary novel investigational medicinal product that contains messenger ribonucleic acid (mRNA) designed as an immunotherapy against HPV16+ cancer developed by eTheRNA immunotherapies.”
The study is made up of 2 Cohorts:
Cohort 1 – incurable patients with HPV16+ tumors
The first Cohort will enroll patients with HPV16+ tumors that are currently incurable (e.g. HNSCC oropharyngeal cancer, cervical, vulvar, vaginal, anal, penile cancer, etc.). This is a dose escalation study with EI-201 as monotherapy. Patients will receive a total of 4 administrations of EI-201 over 3 weeks. The overall study is planned to last between 10 and 14 weeks weeks for each patient. Patients will undergo imaging using CT scanning and during the study, blood and tumour samples will be collected for biomarker analysis and immune monitoring on top of the safety analysis.
Study sites will be announced soon.
Expected to start
Start date to be announced
Cohort 2 – patients with metastatic or recurrent HPV16+ cancer
The second Cohort will include patients with metastatic or recurrent HPV16+ cancer where PD-1 therapy (pembrolizumab) is indicated as first line in HNSCC or second line therapy in other HPV16+ anogenital cancers (Cervical, vulval, vaginal, anal or penile cancer). The overall study will be up to 32 weeks for each patient. Similar to Cohort 1, imaging will be undertaken to follow up tumor burden, and collection of blood and tumor samples for biomarker analysis and immune monitoring on top of the safety analysis. The primary endpoint for Cohort 2 will also be safety and tolerability as an add on to pembrolizumab.