Subcutaneous rilvegostomig with hyaluronidase for adults with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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: 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.

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 or allogeneic stem cell 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 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.
* 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.

Where it's running

• 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 Recruiting
• Research Site
  Seoul, South Korea Recruiting
• Research Site
  Barcelona, Spain Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.