Seattle Genetics has dosed the first patient in the innovaTV 204 trial, a Phase ll study examining the efficacy, safety and tolerability of tisotumab vedotin as monotherapy for treating patients with recurrent and/or metastatic cervical cancer.
The global, multicentre, single arm trial will include around 100 patients with recurrent and/or metastatic cervical cancer who progressed on or relapsed after treatment with platinum-based chemotherapy used alone or in combination with bevacizumab (Avastin).
As part of the trial, the patients will receive single-agent tisotumab vedotin every three weeks.
The trial’s primary goal is objective response rate as assessed by independent review.
Its key secondary endpoints comprise duration of response, progression-free survival, overall survival, safety and tolerability.
innovaTV 204 trial principal investigator Robert Coleman said: “While significant advances have been made in the treatment and prevention of cervical cancer, there remains a need for targeted agents that are effective for patients who progress or relapse after standard treatments.
“In a prior study, tisotumab vedotin demonstrated encouraging results in previously treated recurrent and/or metastatic cervical cancer, an area of unmet need where there is no established standard of care and response rates are limited.”
Tisotumab vedotin is an investigational antibody-drug conjugate (ADC) currently being developed by Seattle Genetics along with Genmab.
It is designed to target Tissue Factor antigen on cancer cell surfaces and deliver the cell-killing agent monomethyl auristatin E (MMAE) directly inside cancer cells.
Seattle Genetics, in collaboration with Genmab, also plans to examine tisotumab vedotin in other solid tumours with unmet medical need for new treatment options.