The Investigational New Drug (IND) application cross-references the open envafolimab IND maintained by TRACON’s corporate partners 3D Medicines and Alphamab Oncology, TRACON said in a statement Thursday.
The company previously reported results of a May 8 teleconference with the FDA whereby the agency agreed with TRACON’s proposals regarding key elements of the ENVASARC trial for envafolimab in the soft tissue sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma.
READ: TRACON Pharmaceuticals to host key opinion leader webinar on envafolimab for the treatment of sarcoma on July 17
San Deigo-based TRACON said it expects to initiate enrollment in the ENVASARC trial at 25 sites in the US in the second half of 2020.
Key elements for the ENVASARC pivotal trial include:
- Multi-center, open-label, randomized, non-comparative, parallel cohort study.
- Eligible patients will have received one or two prior cancer therapies, but no prior immune checkpoint inhibitor therapy.
- Planned total enrollment of 160 patients, with 80 patients enrolled into cohort A of treatment with single-agent envafolimab and 80 patients enrolled in cohort B of treatment with envafolimab and Yervoy.
- The primary endpoint of objective response rate with the duration of response a key secondary endpoint.
- Open-label format with a blinded independent central review of efficacy endpoint data.
TRACON's stock recently traded up by 2% to $2.01 a share in New York.
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