Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

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

Sponsor: AstraZeneca

NCT ID: NCT07161414

View on ClinicalTrials.gov ↗

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.

Advanced Solid Tumors

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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 Is This Study? (2 UK sites)

Research Site

Newcastle upon Tyne NE7 7DN, United Kingdom

WITHDRAWN

Research Site

Sutton SM2 5PT, United Kingdom

WITHDRAWN

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09