At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- IV Rilvegostomig (drug), Recombinant Human Hyaluronidase (rHu) (drug), SC Rilvegostomig (drug), SC rilvegostomig + rHu (drug)
- How long the study runs
- Study runs about 44 months (dates as stated)
- About the drug or intervention
- IV Rilvegostomig — drug: Rilvegostomig administered IV. · Recombinant Human Hyaluronidase (rHu) — drug: rHu administered subcutaneously. · SC Rilvegostomig — drug: Rilvegostomig administered subcutaneously. · SC rilvegostomig + rHu — drug: SC rilvegostomig + rHu administered subcutaneously.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 40
- Started
- 2025-11-25
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for advanced solid tumors
- • Phase1 - 40 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced solid tumors
Where?
- • Newcastle upon Tyne - Research Site
- • Sutton - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
This is a Phase I, open-label, multicenter, multi-part, dose finding and dose confirmation study to evaluate the PK and safety of SC rilvegostomig. The study includes 2 parts: Part 1 (Dose Finding) and Part 2 (Dose Confirmation). Part 1 will determine a SC rilvegostomig dose co-administered with rHu that yields drug exposure comparable with IV rilvegostomig. It will include 2 planned dose levels (DL1 in Cohort A and DL2 in Cohort B). Additional dose levels may be added, if needed. Part 2 will be initiated once a dose has been identified based on Part 1. This part will evaluate the bioavailability, safety, and tolerability of SC rilvegostomig + rHu.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Histologically or cytologically documented advanced (that has spread and/or unresectable) solid tumor.
- ✓IO monotherapy considered clinically appropriate and reasonably likely to permit study participation through at...
- ✓activity scale (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.
Who cannot take part
- ✗Any severe or uncontrolled systemic diseases, which makes it undesirable for the participant to participate in the...
- ✗History of organ transplant or allogeneic stem cell transplant.
- ✗History of another primary cancer that was active within past 2 years.
- ✗Persistent toxicities caused by previous anticancer treatment(s) excluding alopecia, not yet improved to Grade ≤ 1...
- ✗Unstable, causing symptoms brain metastasis or spinal cord compression.
See the full criteria
Where Is This Study? (2 UK sites)
Research Site
Newcastle upon Tyne NE7 7DN, United Kingdom
Research Site
Sutton SM2 5PT, United Kingdom
How to Get in Touch
AstraZeneca Clinical Study Information Center
Sponsor contactCONTACT
