Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-08
40
Participants Needed
11
Research Sites
191 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumor
- Prior anticancer treatment for the disease under study
- Immuno-oncology monotherapy considered suitable by the investigator
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no decline
- Life expectancy of at least 12 weeks at enrollment
- Adequate organ and marrow function
- Body weight of 30 kg or more
You will not qualify if you...
- Severe or uncontrolled systemic diseases that could interfere with study participation or protocol compliance
- History of organ transplant
- Another primary cancer active within the last 2 years
- Persistent toxicities from prior anticancer treatments worse than Grade 1 or baseline, except hair loss
- Unstable or symptomatic brain metastasis or spinal cord compression
- History of leptomeningeal carcinomatosis
- Active primary immunodeficiency or active infections including tuberculosis, HIV, or hepatitis A, B, or C
- History of serious heart conditions including arrhythmia, cardiomyopathy, congestive heart failure, or recent myocardial infarction within 6 months
- Uncontrolled illnesses like infections, interstitial lung disease, serious chronic gastrointestinal conditions with diarrhea, or active skin diseases needing systemic treatment
- Active or prior autoimmune or inflammatory disorders needing chronic steroid or immunosuppressive treatment
- Known allergy or sensitivity to rilvegostomig, hyaluronidase, or any study drug ingredients
- Previous immunotherapy causing permanent discontinuation due to toxicity
- Any anticancer treatment including immunotherapy within 28 days before starting the study drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Research Site
Huntersville, North Carolina, United States, 28078
Actively Recruiting
2
Research Site
San Antonio, Texas, United States, 78229
Actively Recruiting
3
Research Site
Fairfax, Virginia, United States, 22031
Actively Recruiting
4
Research Site
Seoul, South Korea, 03080
Not Yet Recruiting
5
Research Site
Seoul, South Korea, 03722
Not Yet Recruiting
6
Research Site
Barcelona, Spain, 08035
Not Yet Recruiting
7
Research Site
Barcelona, Spain, 08036
Actively Recruiting
8
Research Site
Madrid, Spain, 28027
Actively Recruiting
9
Research Site
Madrid, Spain, 28040
Actively Recruiting
10
Research Site
Newcastle upon Tyne, United Kingdom, NE7 7DN
Suspended
11
Research Site
Sutton, United Kingdom, SM2 5PT
Suspended
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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