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
NCT07161414 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-08
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.
Conditions
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.
Sponsors & Collaborators
-
Parexel
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-25
- Primary Completion
- 2027-07-19
- Completion
- 2029-07-24
- FDA Drug
- Yes
Countries
- United States
- South Korea
- Spain
- United Kingdom
Study Locations
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