NCT07161414 · AstraZeneca
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
(ARTEMIDE-subQ)
What this study is about
The purpose of this study is to determine the injected under the skin (SC) dose that gives rilvegostomig exposure comparable to the given through a vein (IV) (IV) exposure, and to evaluate the how the drug moves through the body (PK) and safety of SC rilvegostomig in adult participants with advanced solid tumors previously treated with the usual treatment therapy for whom immunooncology (IO) treatment given alone would be deemed appropriate by the investigator.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 participant to participate in the study or that would jeopardize compliance with the protocol.
- History of organ transplant.
- History of another primary malignancy that was active within past 2 years.
- Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Unstable, symptomatic brain metastasis or spinal cord compression.
- History of leptomeningeal carcinomatosis.
- Active primary immunodeficiency/active infectious disease including tuberculosis (TB), human immunodeficiency virus (HIV) infection or hepatitis A, B or C infection.
- History of clinically significant arrhythmia, cardiomyopathy of any etiology; symptomatic congestive heart failure, history of myocardial infarction within the past 6 months.
- Uncontrolled intercurrent illness including but not limited to ongoing or active known infection; interstitial lung disease (ILD), serious chronic gastrointestinal conditions associated with diarrhea; active non-infectious skin disease requiring systemic treatment.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- Known allergy or hypersensitivity to rilvegostomig, hyaluronidase, or any excipients of the investigational products.
- Participants experienced a toxicity to prior immunotherapy that led to permanent discontinuation of prior immunotherapy.
- Prior anticancer treatment, including immunotherapy, up to 28 days prior to the first dose of study treatment.
Where
- Huntersville, North Carolina
- San Antonio, Texas
- Fairfax, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations