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Study of Subcutaneous Rilvegostomig for Advanced Solid Tumors

This study is looking at a new way to give a cancer medicine called rilvegostomig to adults with advanced solid tumors that have already been treated with standard therapies. Currently, rilvegostomig is given through a vein (IV), but this study wants to see if it can be given as a shot under the skin (subcutaneous or SC). Researchers will compare how much rilvegostomig gets into your body when given as an IV versus a SC shot, sometimes with another medicine called recombinant human hyaluronidase (rHu). The main goal is to find a SC dose that provides similar drug levels to the IV dose, while also checking for safety. This is for people whose doctors think immunotherapy (a treatment that helps your immune system fight cancer) would be a good option for them. The study plans to enroll about 40 participants.

Study design
This is an early-stage (Phase I), open-label study, meaning you and your doctors will know which treatment you are receiving. It involves multiple centers and is designed to find and confirm the best dose of SC rilvegostomig.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main measurements for drug levels will be taken from Day 1 up to the end of Cycle 2 in Part 1, and up to the end of Cycle 1 in Part 2. Each cycle will last 3 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07161414

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
AstraZeneca
~40 participants
Updated 2026-09-01 on ClinicalTrials.gov
What's tested:IV RilvegostomigRecombinant Human Hyaluronidase (rHu)SC RilvegostomigSC rilvegostomig + rHu

At a glance

Recruiting sites
8 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the Concentration-time Curve During One Dosing Interval (AUCtau)
Measured over From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)

Conditions

Advanced Solid Tumors

Explore related trials

Solid Neoplasm

NCT07161414

Where you'd take part

This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Research Site

    Huntersville, North Carolinano site contact published

    Recruiting

  • Research Site

    San Antonio, Texasno site contact published

    Recruiting

  • Research Site

    Fairfax, Virginiano site contact published

    Recruiting

  • Research Site

    Seoul, South Koreano site contact published

    Recruiting

  • Research Site

    Seoul, South Koreano site contact published

    Recruiting

  • Research Site

    Barcelona, Spainno site contact published

    Not yet recruiting

  • Research Site

    Barcelona, Spainno site contact published

    Recruiting

  • Research Site

    Madrid, Spainno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Area under the Concentration-time Curve During One Dosing Interval (AUCtau)From Day 1 up to end of Cycle 2 in Part 1 and end of Cycle 1 in Part 2 (each cycle will be of 3 weeks)

    Bioavailability based on AUCtau at first SC dose will be determined.