Actively Recruiting

Phase 1
Age: 18Years +
All Genders
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

Led by AstraZeneca · Updated on 2026-05-08

40

Participants Needed

11

Research Sites

191 weeks

Total Duration

On this page

Sponsors

A

AstraZeneca

Lead Sponsor

P

Parexel

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically or cytologically confirmed advanced (metastatic and/or unresectable) solid tumor
  • Prior anticancer treatment for the disease under study
  • Immuno-oncology monotherapy considered suitable by the investigator
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 with no decline
  • Life expectancy of at least 12 weeks at enrollment
  • Adequate organ and marrow function
  • Body weight of 30 kg or more
Not Eligible

You will not qualify if you...

  • Severe or uncontrolled systemic diseases that could interfere with study participation or protocol compliance
  • History of organ transplant
  • Another primary cancer active within the last 2 years
  • Persistent toxicities from prior anticancer treatments worse than Grade 1 or baseline, except hair loss
  • Unstable or symptomatic brain metastasis or spinal cord compression
  • History of leptomeningeal carcinomatosis
  • Active primary immunodeficiency or active infections including tuberculosis, HIV, or hepatitis A, B, or C
  • History of serious heart conditions including arrhythmia, cardiomyopathy, congestive heart failure, or recent myocardial infarction within 6 months
  • Uncontrolled illnesses like infections, interstitial lung disease, serious chronic gastrointestinal conditions with diarrhea, or active skin diseases needing systemic treatment
  • Active or prior autoimmune or inflammatory disorders needing chronic steroid or immunosuppressive treatment
  • Known allergy or sensitivity to rilvegostomig, hyaluronidase, or any study drug ingredients
  • Previous immunotherapy causing permanent discontinuation due to toxicity
  • Any anticancer treatment including immunotherapy within 28 days before starting the study drug

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 11 locations

1

Research Site

Huntersville, North Carolina, United States, 28078

Actively Recruiting

2

Research Site

San Antonio, Texas, United States, 78229

Actively Recruiting

3

Research Site

Fairfax, Virginia, United States, 22031

Actively Recruiting

4

Research Site

Seoul, South Korea, 03080

Not Yet Recruiting

5

Research Site

Seoul, South Korea, 03722

Not Yet Recruiting

6

Research Site

Barcelona, Spain, 08035

Not Yet Recruiting

7

Research Site

Barcelona, Spain, 08036

Actively Recruiting

8

Research Site

Madrid, Spain, 28027

Actively Recruiting

9

Research Site

Madrid, Spain, 28040

Actively Recruiting

10

Research Site

Newcastle upon Tyne, United Kingdom, NE7 7DN

Suspended

11

Research Site

Sutton, United Kingdom, SM2 5PT

Suspended

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Research Team

A

AstraZeneca Clinical Study Information Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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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 | DecenTrialz