A Study of SGN-TGT in Subjects with Advanced Malignancies

• Research type

  Research Study

• Full title

  A Phase 1 Study of SGN-TGT in Subjects with Advanced Malignancies

• IRAS ID

  276806

• Contact name

  Anna Minchom

• Contact email

  Anna.Minchom@icr.ac.uk

• Sponsor organisation

  Seattle Genetics, Inc.

• Eudract number

  2019-004748-31

• Clinicaltrials.gov Identifier

  NCT04254107

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  2 years, 6 months, 0 days

• Research summary

  This study is being carried out to test if SGN-TGT (investigational drug) is safe and effective for the treatment of advanced cancer.
  SGN-TGT is a type of drug called a monoclonal antibody. Antibodies are part of our immune system to help protect against infection. Cancer cells often turn off the immune system or turn it down, which lets the cancer keep growing. SGN-TGT is designed to help turn on your immune system so it can find and remove cancer cells.
  We are asking patients who have one of the following types of cancers to participate in this study: Lung cancer, Gastric cancer, Hodgkin lymphoma (HL), Diffuse large B-cell lymphoma (DLBCL) and Peripheral T-cell lymphoma (PTCL).

  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 SGN-TGT on Day 1 of each 21 day cycle. Participants will have various procedures throughout the study including urinalysis, blood samples, MRI, PET,CT scans, ECGs and tumour biopsies. 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.
  Study has 3 parts: A, B, and C. Parts A and B will test SGN-TGT given alone. Part C will test SGN-TGT given with another drug called pembrolizumab (also called KEYTRUDA ®).Before we combine SGN TGT with pembrolizumab, we must find out if it’s safe to give it by itself.

  Around 111 people will take part in this clinical trial globally at 11 study centers in US, UK, France, Italy and Spain. About 85 people will take part in Parts A and B. About 26 people will take part in Part C. This study is being sponsored by Seattle Genetics, Inc.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  20/LO/0696

• Date of REC Opinion

  30 Jun 2020

• REC opinion

  Further Information Favourable Opinion