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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

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

40 Participants
are divided into 3 treatment groups

Sponsors and collaborators

AstraZeneca

Lead sponsor

Parexel

Collaborator