TRACON Pharmaceuticals (NASDAQ:TCON), which develops a clinical-stage pipeline of cancer therapies, announced Thursday the dosing of the first patient in the ENVASARC registration trial to treat soft-tissue sarcoma cancer.
The pivotal study, which will involve 25 top cancer centers in the US, will assess the potential of envafolimab as a single agent and in combination with monoclonal antibody Yervoy (ipilimumab), which is used to treat late-stage, metastatic melanoma.
“We are pleased to initiate dosing in the ENVASARC registration trial of envafolimab in sarcoma,” said Dr Sant Chawla, director of the Sarcoma Oncology Center in Santa Monica. “Immunotherapy has radically changed the treatment paradigm for a number of cancers, and we believe envafolimab has the potential to do the same for sarcoma patients who have few treatment options.”
The trial will be a multi-center, open-label, randomized, non-comparative, parallel cohort study. Planned total enrollment is 160 patients -- with 80 patients enrolled into cohort A of treatment with envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
San Diego-based TRACON said eligible patients will have undifferentiated pleomorphic sarcoma (UPS) or myxofibrosarcoma (MFS) and received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
“Dosing the first patient in the ENVASARC registration trial within one year of executing the license to envafolimab fulfills our 2020 expectations for what has been a productive year of clinical development and regulatory interactions for our lead product candidate,” said Dr Charles Theuer, CEO of TRACON, in a statement.
“We look forward to the availability of interim top-line data from this important study, which we expect in mid-2021.”
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