Phase 2 Study of LV in Advanced Solid Tumors
Research type
Research Study
Full title
Open-Label Phase 2 Study of Ladiratuzumab Vedotin (LV) for Unresectable Locally Advanced or Metastatic Solid Tumors
IRAS ID
271255
Contact name
Ian Chau
Contact email
Sponsor organisation
Seattle Genetics, Inc.
Eudract number
2019-001946-17
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND 117532, IND number
Duration of Study in the UK
0 years, 7 months, 29 days
Research summary
Patients with advanced solid tumours generally have poor outcomes. There have been some advances with the introduction of a type of medication called anti-programmed death 1 or programmed death ligand 1 (PD[L]1) therapies, but there still is an unmet need in patients whose disease progresses following these treatments, or for those patients who are not suitable for these therapies. Although chemotherapy often remains as the chosen treatment option for these patients, it is usually associated with poor responses and high toxicity (side effects).
Ladiratuzumab Vedotin (LV) is an antibody-drug conjugate, which is directed against the LIV-1 antigen (a protein on human cell surface) that is being developed to treat participants with solid tumours. LIV-1 expression has been detected in a number of cancer types including breast, prostate, melanoma, ovarian, bladder, small cell lung cancer, non- small cell lung cancer, head and neck squamous cell carcinoma.
LV is a medication with targeted delivery (meaning the medication is targeted at tumours) and may have increased effectiveness and safety in treating patients with solid tumours.
This is a global, open-label, multicentre phase 2 study designed to assess the activity, safety, and tolerability of LV monotherapy in adults with cancer in 6 cohorts (group); small cell lung cancer, non-small cell lung cancer-squamous, non-small cell lung cancer–nonsquamous, head and neck squamous cell carcinoma, oesophageal squamous cell carcinoma, and gastric and gastroesophageal junction adenocarcinoma.
Up to 180 participants may be enrolled in the study with up to 30 in each cohort. LV will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle. The participants will continue to receive study treatment until disease progression, unacceptable toxicity, investigator decision, consent withdrawal, study termination, pregnancy or death, whichever comes first. The study will be run at sites in Europe, USA, Australia, Korea and Taiwan.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/1541
Date of REC Opinion
29 Nov 2019
REC opinion
Further Information Favourable Opinion