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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- IV Rilvegostomig
- Recombinant Human Hyaluronidase (rHu)
- SC Rilvegostomig
- SC rilvegostomig + rHu
Treatment groups
Sponsors and collaborators
AstraZeneca
Lead sponsor
Parexel
Collaborator