A Phase I, Multicenter, Dose Finding and Dose Confirmation Study to Investigate the Pharmacokinetics, and Safety of Subcutaneous Rilvegostomig in Adult Participants With Advanced Solid Tumors Previously Treated With Standard of Care Therapy (ARTEMIDE-subQ)
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.
Arms & interventions
- DrugIV Rilvegostomig
Rilvegostomig administered IV.
- DrugRecombinant Human Hyaluronidase (rHu)
rHu administered subcutaneously.
- DrugSC Rilvegostomig
Rilvegostomig administered subcutaneously.
- DrugSC rilvegostomig + rHu
SC rilvegostomig + rHu administered subcutaneously.
Outcome measures
Primary
Area under the Concentration-time Curve During One Dosing Interval (AUCtau)
Bioavailability based on AUCtau at first SC dose will be determined.
Time frame: From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)
Secondary
Number of participants with adverse events (AEs)
Time frame: From Day 1 up to 90 days post last dose (Up to approximately 29 months)
Observed Lowest Concentration before the Next Dose is Administered (Ctrough)
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).
Average drug concentration over a dosing interval (Cavg)
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).
AUCtau
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).
Serum rilvegostomig concentration
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).
Eligibility criteria
Study locations (3)
Research Site
Huntersville, North Carolina, 28078
Research Site
San Antonio, Texas, 78229
Research Site
Fairfax, Virginia, 22031