innovaTV 207
Research type
Research Study
Full title
Open Label Phase 2 Study of Tisotumab Vedotin for Locally Advanced or Metastatic Disease in Solid Tumours
IRAS ID
250033
Contact name
Kevin Harrington
Contact email
Sponsor organisation
Seagen Inc
Eudract number
2017-005076-26
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
138037, IND Reference
Duration of Study in the UK
2 years, 5 months, 31 days
Research summary
This study is being carried out to evaluate the safety, tolerability and activity of tisotumab vedotin (investigational drug) with patients for the treatment of solid tumours.
Tisotumab vedotin is a type of drug called an antibody drug conjugate or ADC. ADCs usually have 2 parts – antibody and drug. The antibody part is designed to stick to cancer cells so that the drug part can be absorbed into the cancer cells causing cell death. We are asking patients who have one of four cancer types (colorectal, squamous non-small cell lung, pancreatic, squamous cell of the head and neck) to take part in this study.
This is an open label study, which means both the participants and study team know what drug is being given. All participants will be administered tisotumab vedotin on Day 1 of each 21 day cycle. Participants will continue to receive study treatment and safety assessment until disease progression, toxicity, investigators decision or withdrawal of consent. After treatment discontinuation, all patients will be followed for subsequent cancer therapies and survival.
Around 200 patients may take part in the clinical trial. This study is being sponsored by Seattle Genetics, Inc.REC name
London - South East Research Ethics Committee
REC reference
18/LO/1721
Date of REC Opinion
20 Dec 2018
REC opinion
Further Information Favourable Opinion