A Phase I, Multicentre, Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab in Adult Participants with Solid Tumours (IMFINZI-subQ)

Condition studied

• Non-small cell lung cancer (Stage III, unresectable) • Small cell lung cancer (Limited stage) • Hepatocellular carcinoma (Unresectable)

Investigational medicinal product(s)

Eligibility

Primary endpoint

AUC and Ctrough

Endpoint detail

Other PK parameters (including Ctrough, AUClast, Cmax, tmax, t1/2λz, CL(/F),Vz(/F), and Cavg) and serum durvalumab concentrations at specified timepoints., DLT assessment, AEs (including SC site of administration-related AEs), physical examination, clinical laboratory assessments, vital signs, and ECOG performance status.