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RECRUITING
NCT07161414
PHASE1

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-11-25

Completion Date

2029-07-24

Last Updated

2026-04-09

Healthy Volunteers

No

Interventions

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.

Locations (11)

Research Site

Huntersville, North Carolina, United States

Research Site

San Antonio, Texas, United States

Research Site

Fairfax, Virginia, United States

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Barcelona, Spain

Research Site

Barcelona, Spain

Research Site

Madrid, Spain

Research Site

Madrid, Spain

Research Site

Newcastle upon Tyne, United Kingdom

Research Site

Sutton, United Kingdom