A Study of SGN-B6A in Advanced Solid Tumors
Research type
Research Study
Full title
A Phase 1 Study of SGN-B6A in Advanced Solid Tumors
IRAS ID
284885
Contact name
Anna Minchom
Contact email
Sponsor organisation
Pfizer Europe
Eudract number
2020-001035-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
3 years, 3 months, 27 days
Research summary
This study is being carried out to test if SGN-B6A (investigational drug) is safe and effective for the treatment of solid tumours.
SGN-B6A is a type of drug called an antibody drug conjugate (ADC). ADCs usually have 2 parts – antibody and drug. Antibodies are part of our immune system to help protect against infection and the drug component are designed to target specific 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 the following types of cancers to participate in this study: Non-small cell lung cancer,Cutaneous squamous cell cancer,Head and neck squamous cell cancer,Exocrine pancreatic carcinoma,Breast cancer,Bladder cancer,Esophageal cancer,Cervical cancer,Ovarian cancer and Gastric cancer.
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-B6A on Day 1, Day 8 and Day 15 of each 21 day cycle. Participants will have various
procedures throughout the study including urinalysis, blood samples, MRI/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 2 Parts: A and B. Part A- The maximum tolerated dose (MTD - The highest dose of a drug or treatment that does not cause unacceptable side effects) of SGN-B6A in participants with advanced solid tumours will be identified.
Part B:The recommended dose of SGN-B6A for further testing and/or the treatment of patients with select advanced solid tumours.
Around 235 patients may take part in the clinical trial globally at 11 study centers in US, UK, France, Italy and Spain.
This study is being sponsored by Seattle Genetics, Inc.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
20/WM/0248
Date of REC Opinion
23 Nov 2020
REC opinion
Further Information Favourable Opinion