A Study of SGN-STNV in Advanced Solid Tumours

Official Title

A Phase 1 Study of SGN-STNV in Advanced Solid Tumours

Summary:

This trial will look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumours. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumours. The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumours.

Trial Description

Primary Outcome:

• Incidence of adverse events (AEs)
• Incidence of laboratory abnormalities
• Incidence of dose limiting toxicities

Secondary Outcome:

• Objective response rate (ORR) as assessed by the investigator per RECIST v1.1
• Progression-free survival (PFS)
• Overall survival (OS)
• Duration of objective response (DOR)
• Area under the concentration-time curve (AUC)
• Time to maximum concentration (Tmax)
• Maximum concentration (Cmax)
• Trough concentration (Ctrough)
• Incidence of antidrug antibodies (ADA)

The study will include dose escalation (Part A) and dose expansion (Part B), with multiple disease-specific cohorts and a biology cohort in dose expansion. The biology cohort will be gated based on data generated from other expansion cohorts and will require additional biopsies. At the completion of dose escalation, up to 5 disease specific expansion cohorts and 1 biology expansion cohort may be activated by the sponsor in consultation with the Safety Monitoring Committee (SMC). Expansion cohorts in Part B will enroll subjects with selected tumours that are eligible for enrollment in Part A. The dose(s) to be examined in Part B will be at or below the maximum tolerated dose and/or the recommended dose determined in Part A. The recommended dose and/or schedule may differ between cohorts.

View this trial on ClinicalTrials.gov