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June 15, 2018updated 13 Jul 2022 9:14am

Seattle Genetics doses first patient in innovaTV 204 trial

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.

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.

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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.

“There remains a need for targeted agents that are effective for patients who progress or relapse after standard treatments.”

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.

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As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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