A study of SGN-PDL1V in advanced solid tumors
Research type
Research Study
Full title
A phase 1 study of SGN-PDL1V in advanced solid tumors
IRAS ID
1005050
Contact name
Andres Forero-Torres
Contact email
Sponsor organisation
Seagen Inc
Eudract number
2021-003517-19
Clinicaltrials.gov Identifier
Research summary
Study SGN-PDL1V is a phase 1, open-label, multicenter study designed to evaluate the safety, tolerability, PK, and antitumour activity of SGN-PDL1V in adults with select advanced solid tumours.
The study will include multiple tumour types for the dose escalation (Part A), followed by cohorts for dose and schedule optimization (Part B, optional), and disease-specific cohorts in dose expansion (Part C).
The study will include dose escalation (Part A) enrolling participants with head and neck squamous cell cancer (HNSCC) HNSCC, non-small cell lung cancer (NSCLC), or esophageal SCC who have programmed death -ligand 1 (PD-L1) expression ≥1 by combined positive score (CPS) or tumour proportion score (TPS) based on historical testing.
At the completion of dose escalation, dose and schedule optimization (Part B) may be activated to additionally
evaluate up to two of the SGN-PDL1V dosing schedules recommended from Part A in 2 different tumour types. This part will allow optimization of the dose and schedule that will be recommended for expansion.Part Dose expansion in participants with head and neck squamous cell cancer (HNSCC) only will be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC) using the dose and schedule identified by Part A or Part B.
Approximately 85 subjects may be enrolled in Parts A and B of this study based on the assumption that approximately 45 subjects are expected to be evaluated in dose-escalation in Part A and approximately 40 subjects may be evaluated for dose and schedule optimization in Part B.
Approximately 220 subjects may be evaluated in the dose expansion cohorts, signal seeking cohort, and biology cohort in Part C.REC name
London - Surrey Borders Research Ethics Committee
REC reference
22/LO/0288
Date of REC Opinion
1 Jun 2022
REC opinion
Further Information Favourable Opinion