Subcutaneous rilvegostomig with hyaluronidase for adults with advanced solid tumors

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)

This trial will test whether subcutaneous rilvegostomig given with recombinant human hyaluronidase produces drug levels similar to the intravenous form in adults with advanced solid tumors who have already received standard treatments and are suitable for immuno-oncology monotherapy.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AstraZeneca (industry)
• Drugs / interventions: immunotherapy
• Locations: 11 sites (Huntersville, North Carolina and 10 other locations)
• Trial ID: NCT07161414 on ClinicalTrials.gov

What this trial studies

This Phase I, open-label, multicenter trial uses a two-part design to find and confirm a subcutaneous (SC) dose of rilvegostomig that matches intravenous (IV) exposure when co-administered with recombinant human hyaluronidase (rHu). Part 1 is a dose-finding stage with planned cohorts to identify an SC dose that yields comparable pharmacokinetics to IV rilvegostomig, with additional dose levels allowed if needed. Part 2 will confirm bioavailability, safety, and tolerability of the selected SC dose plus rHu. The study will include PK sampling, safety monitoring, and routine oncology assessments in adults with previously treated advanced solid tumors.

Who should consider this trial

Good fit: Adults with histologically or cytologically confirmed advanced (metastatic or unresectable) solid tumors who have received prior anticancer treatment, are appropriate for immuno-oncology monotherapy, have ECOG performance status 0–1, adequate organ and marrow function, and weigh at least 30 kg.

Not a fit: Patients with uncontrolled severe systemic disease, a history of organ transplant, recent active second primary malignancy, unstable symptomatic brain metastases or spinal cord compression, or persistent high-grade toxicities from prior therapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, patients could receive rilvegostomig by subcutaneous injection with similar drug exposure to IV dosing, which may be more convenient and reduce infusion visits.

How similar studies have performed: Recombinant human hyaluronidase has been used successfully to enable subcutaneous delivery of other oncology biologics, but applying this approach to rilvegostomig—a bispecific immunotherapy targeting TIGIT and PD‑1—is an early and relatively novel application.

Eligibility criteria

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 this trial is running

Huntersville, North Carolina and 10 other locations

• Research Site — Huntersville, North Carolina, United States (RECRUITING)
• Research Site — San Antonio, Texas, United States (RECRUITING)
• Research Site — Fairfax, Virginia, United States (RECRUITING)
• Research Site — Seoul, South Korea (NOT_YET_RECRUITING)
• Research Site — Seoul, South Korea (NOT_YET_RECRUITING)
• Research Site — Barcelona, Spain (NOT_YET_RECRUITING)
• Research Site — Barcelona, Spain (RECRUITING)
• Research Site — Madrid, Spain (RECRUITING)
• Research Site — Madrid, Spain (RECRUITING)
• Research Site — Newcastle upon Tyne, United Kingdom (SUSPENDED)
• Research Site — Sutton, United Kingdom (SUSPENDED)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions: Advanced Solid Tumors, Recombinant Human Hyaluronidase, Immunooncology monotherapy, T cell Immunoglobulin and Immunoreceptor Tyrosine-based Inhibitory Motif Domain, Programmed Cell Death Protein 1, Bispecific immunotherapy, Checkpoint inhibitor