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

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).

Trial Details

NCT ID
NCT07391670
Phase
PHASE1
Sponsor
AstraZeneca
Status
RECRUITING
Cancer Type
Adenocarcinoma Lung Cancer
Interventions
  • SC durvalumab + rHu
  • IV durvalumab
  • Tremelimumab
Locations (sample)
  • Fitzroy, Australia|-37.79839,144.97833
  • St Albans, Australia|-37.74496,144.80049
  • Woolloongabba, Australia|-27.48855,153.03655
  • Batumi, Georgia|41.64077,41.6306
  • Tbilisi, Georgia|41.69143,44.83412

Key Eligibility Criteria

  • 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.

For full eligibility, visit ClinicalTrials.gov.

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