Phase IIIa Study Evaluating AZD9574 Alone and Combined With Other Cancer Drugs in Adults With Advanced Solid Tumors

What this Trial Is About

Researchers are evaluating AZD9574 as a treatment for adults with advanced solid cancers that have returned or worsened after prior treatments. This phase IIIa study aims to assess the safety, tolerability, how the drug moves through and affects the body, and early signs of effectiveness of AZD9574 alone and combined with other cancer drugs. The study includes several modules focusing on different cancer types and drug combinations, enrolling approximately 695 participants. Participants will receive AZD9574 orally either alone or with other drugs such as temozolomide, trastuzumab deruxtecan, or datopotamab deruxtecan, depending on their cancer type and the study module. The study includes dose escalation phases to find appropriate dosing and dose expansion phases to further evaluate the treatments. Some participants will also be involved in a PET sub-study using intravenous 11CAZ1419 3391. Treatment cycles vary by module, with some lasting up to 12 cycles or longer. During the study, participants will undergo regular assessments including monitoring for adverse events, blood tests, imaging scans like MRI, and performance status evaluations. Researchers will measure changes in tumor size, response rates, progression-free survival, and specific biomarkers related to the cancers studied. Safety and drug levels in the body will be tracked from the first dose through approximately three years of follow-up. Participants may also provide tissue samples and undergo biopsies as part of the study evaluations.

Study of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Malignancies