A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy
Start Date
11/25/2025
Completion Date
7/24/2029
Summary
The purpose of this study is to determine the subcutaneous (SC) dose that gives rilvegostomig exposure comparable to the intravenous (IV) exposure, and to evaluate the pharmacokinetics (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with standard of care therapy for whom immunooncology (IO) monotherapy would be deemed appropriate by the investigator.
Detailed Description
This is a Phase I, open-label, multicenter, multi-part, dose finding and dose confirmation study to evaluate the PK and safety of SC rilvegostomig. The study includes 2 parts: Part 1 (Dose Finding) and Part 2 (Dose Confirmation). Part 1 will determine a SC rilvegostomig dose co-administered with rHu that yields drug exposure comparable with IV rilvegostomig. It will include 2 planned dose levels (DL1 in Cohort A and DL2 in Cohort B). Additional dose levels will be added, if needed. Part 2 will be initiated once a dose has been identified based on Part 1. This part will evaluate the bioavailability, safety, and tolerability of SC rilvegostomig + rHu.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
IV Rilvegostomig
Recombinant Human Hyaluronidase (rHu)
SC Rilvegostomig
SC rilvegostomig + rHu
Conditions
Locations
Research Site
Huntersville, North Carolina 28078
United States
Research Site
San Antonio, Texas 78229
United States
Research Site
Fairfax, Virginia 22031
United States
Research Site
Seoul, 03080
South Korea
Research Site
Seoul, 03722
South Korea
Research Site
Barcelona, 08035
Spain
Research Site
Barcelona, 08036
Spain
Research Site
Madrid, 28027
Spain
Research Site
Madrid, 28040
Spain
Research Site
Newcastle upon Tyne, NE7 7DN
United Kingdom
Research Site
Sutton, SM2 5PT
United Kingdom