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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Rilvegostomig administered IV.
rHu administered subcutaneously.
Rilvegostomig administered subcutaneously.
SC rilvegostomig + rHu administered subcutaneously.
Research Site
Huntersville, North Carolina, United States
RECRUITINGResearch Site
San Antonio, Texas, United States
RECRUITINGResearch Site
Fairfax, Virginia, United States
RECRUITINGResearch Site
Seoul, South Korea
NOT_YET_RECRUITINGResearch Site
Barcelona, Spain
NOT_YET_RECRUITINGResearch Site
Barcelona, Spain
NOT_YET_RECRUITINGResearch Site
Madrid, Spain
NOT_YET_RECRUITINGResearch Site
Madrid, Spain
NOT_YET_RECRUITINGResearch Site
Newcastle upon Tyne, United Kingdom
NOT_YET_RECRUITINGResearch Site
Sutton, United Kingdom
NOT_YET_RECRUITINGArea 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)
Number of participants with adverse events (AEs)
To assess safety and tolerability of SC rilvegostomig. Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, physical examinations, and ECOG performance status.
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)
To assess drug exposure (Ctrough) of SC rilvegostomig comparable to that of IV rilvegostomig.
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)
To assess drug exposure (Cavg) of SC rilvegostomig comparable to that of IV rilvegostomig.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).
AUCtau
To assess drug exposure of SC rilvegostomig comparable to that of IV rilvegostomig.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).
Serum rilvegostomig concentration
To assess drug exposure (serum concentration) of SC rilvegostomig comparable to that of IV rilvegostomig.
Time frame: From first dose of study intervention (Day 1), at predefined intervals throughout the administration of rilvegostomig (approximately 29 months).
AstraZeneca Clinical Study Information Center
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.