A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 Alone and With Anti-cancer Agents in Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating AZD9592 in a first-in-human Phase I study involving patients with advanced solid tumors. The study aims to assess the safety, tolerability, early effectiveness, how the drug moves through and affects the body, anti-tumor activity, and immune response when AZD9592 is given alone or with other cancer treatments. This study includes several modules focusing on different tumor types and combinations with other anti-cancer agents. The trial includes three modules. Module 1 tests AZD9592 alone to find safe doses and examine its effects on select solid tumors. Module 2 combines AZD9592 with Osimertinib, an oral tablet, targeting non-small cell lung cancer with specific mutations. Module 3 combines AZD9592 with a regimen of 5-Fluorouracil, Bevacizumab, and Leucovorin given by intravenous infusion to patients with colorectal cancer. Each module has parts to first find safe doses and then to evaluate anti-tumor activity. Participants will have assessments from the time of consent through up to about two years after starting treatment. Researchers will monitor side effects, lab tests, heart function, and tumor responses using imaging. Blood samples will assess drug levels and immune responses. Safety and disease control will be closely watched during treatment and for 30 days after the last dose. The study involves detailed follow-up to evaluate outcomes like response duration, progression-free survival, and overall survival.

First in Human Study of AZD9592 in Solid Tumors