Phase I Study to Test Safety and Drug Levels of Subcutaneous Durvalumab with rHu in Adults with Various Solid Tumors

What this Trial Is About

Researchers are evaluating subcutaneous under the skin durvalumab combined with recombinant human hyaluronidase rHu in adult participants with various solid tumors, including non-small cell lung cancer NSCLC, hepatocellular carcinoma HCC, and limited-stage small cell lung cancer LS-SCLC. The study aims to find a dose of subcutaneous durvalumab that provides similar drug exposure as the intravenous form and to assess its safety and pharmacokinetics in these patients. The study has two parts Part 1 focuses on dose escalation with two planned dose levels of subcutaneous durvalumab plus rHu, followed by intravenous durvalumab at scheduled intervals for participants with NSCLC, LS-SCLC, or unresectable HCC. Part 2 will expand the study to include participants with unresectable HCC using the dose level identified in Part 1. Some participants with unresectable HCC may also receive tremelimumab intravenously. Participants will be monitored over approximately 17 months, with regular assessments of drug levels and safety. The study will measure how much drug is in the body over time and track any adverse events or dose-limiting toxicities. Participants will have evaluations including laboratory tests and clinical assessments to monitor organ function and treatment effects throughout the study duration.

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