NCT07161414

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	IV Rilvegostomig	Rilvegostomig administered IV.
DRUG	Recombinant Human Hyaluronidase (rHu)	rHu administered subcutaneously.
DRUG	SC Rilvegostomig	Rilvegostomig administered subcutaneously.
DRUG	SC rilvegostomig + rHu	SC rilvegostomig + rHu administered subcutaneously.

Timeline

• Start date: 2025-11-25
• Primary completion: 2027-07-19
• Completion: 2029-07-24
• First posted: 2025-09-08
• Last updated: 2026-04-09

Locations

11 sites across 4 countries: United States, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study