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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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
BarcelonaSpainNot yet recruiting
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MadridSpainRecruiting
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Coordinator of this site? Confirm its status
Newcastle upon TyneUnited KingdomWithdrawn
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SuttonUnited KingdomWithdrawn
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Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
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Coordinator of this site? Confirm its status
FairfaxUnited StatesRecruiting
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Coordinator of this site? Confirm its status
HuntersvilleUnited StatesRecruiting
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Coordinator of this site? Confirm its status
San AntonioUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.