A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab

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

About this trial

The purpose of the study is to determine a subcutaneous (SC: under the skin) durvalumab + recombinant human hyaluronidase (rHu) dose that yields systemic drug exposure similar to intravenous (IV: into the veins) durvalumab administration and to evaluate the pharmacokinetics and safety of SC durvalumab + rHu injection in participants with different types of solid tumours (cancers).

Eligibility criteria

Qualifiers

An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Life expectancy of ≥ 12 weeks at enrolment.

Adequate organ and marrow function.

Minimum body weight > 30 kg.

Disqualifiers

Active or prior documented autoimmune disease requiring systemic treatment.

Uncontrolled infection (including human immunodeficiency virus [HIV], hepatitis B or C).

Prior exposure to immune checkpoint inhibitors.

Mixed SCLC and NSCLC histology.

Trial design

Treatments tested in this trial

  • SC durvalumab + rHu
  • IV durvalumab
  • Tremelimumab

Treatment groups

40 Participants
are divided into 3 treatment groups

Sponsors and collaborators