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)
AstraZeneca
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.
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 bioavail…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Histologically or cytologically documented advanced (metastatic and/or unresectable) solid tumor. * Participants must have received prior anticancer treatment for the disease under study. * IO monotherapy deemed appropriate by the investigator. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment with no deterioration. * Minimum life expectancy of ≥ 12 weeks at enrollment. * Adequate organ and marrow function. * Body weight ≥ 30 kg. Exclusion Criteria: * Any severe or uncontrolled systemic diseases, which makes it undesirable for the p…
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.
Locations (11)
- Research SiteHuntersville, North Carolina
- Research SiteSan Antonio, Texas
- Research SiteFairfax, Virginia
- Research SiteSeoul
- Research SiteSeoul
- Research SiteBarcelona