NCT07161414RecruitingPhase 1
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
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)
Source: ClinicalTrials.gov · Last updated 5 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Sept 2025
- Start date
- 25 Nov 2025
- Primary completion date
- 19 Jul 2027
- Lead sponsor
- AstraZeneca
- NCT number
- NCT07161414
- EU CT number
- 2025-521614-26-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 40
- From 25 Nov 2025 to the primary completion date, 19 Jul 2027
- 8 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
- 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.
Other illness
- 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 or allogeneic stem cell transplant.
- History of another primary malignancy that was active within past 2 years.
- History of leptomeningeal carcinomatosis.
- Active primary immunodeficiency/active infectious disease including tuberculosis (TB), human immunodeficiency virus (HIV) infection or hepatitis B or C infection or any other active or uncontrolled infection requiring systemic treatment.
- Clinically significant or uncontrolled cardiovascular disease, including clinically significant arrhythmias, symptomatic heart failure, cardiomyopathy or myocarditis, recent myocardial infarction or unstable angina, or uncontrolled hypertension.
- Active or ongoing interstitial lung disease (ILD)/ pneumonitis, serious chronic gastrointestinal conditions associated with diarrhea; primary immunodeficiency, or non-infectious skin disease requiring systemic treatment.
Other
- Unstable, symptomatic brain metastasis or spinal cord compression.
Who the study is looking for
- Histologically or cytologically documented advanced (metastatic and/or unresectable) solid tumor.
- Participants must have received prior anticancer treatment for the disease under study: this may include chemotherapy, immunotherapy, or targeted therapy as considered standard of care, where clinically appropriate.
- IO monotherapy considered clinically appropriate and reasonably likely to permit study participation through at least the PK-evaluable period, in the investigator's judgment.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| - Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| - Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Withdrawn |
| - Coordinator of this site? Confirm its status | Sutton | United Kingdom | Withdrawn |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| - Coordinator of this site? Confirm its status | Fairfax | United States | Recruiting |
| - Coordinator of this site? Confirm its status | Huntersville | United States | Recruiting |
| - Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.