Phase 12 Study to Evaluate Safety and Effects of AZD8421 Alone or With Other Drugs in Women With Advanced Breast or Ovarian Cancer

What this Trial Is About

Researchers are evaluating AZD8421 alone and in combination with targeted anti-cancer drugs in patients with ER HER2- advanced breast cancer and metastatic high-grade serous ovarian cancer. This first-in-human study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AZD8421, both as a single treatment and combined with other therapies, in participants previously treated for these cancers. The study includes two main treatment modules AZD8421 monotherapy to determine a recommended dose in patients with specific advanced breast and ovarian cancers, and AZD8421 combined with camizestrant and CDK46 inhibitors in advanced breast cancer patients. Participants receive these treatments in cycles, with safety and response monitored closely. The study uses a sequential model to evaluate these approaches. Participants will undergo various assessments including clinical lab tests, vital signs, ECGs, and tumor measurements to monitor treatment effects and safety throughout the study, which includes an approximately 18-month safety follow-up. Researchers will track dose-limiting toxicities, adverse events, response rates, tumor changes, and pharmacokinetic profiles during treatment and follow-up periods.

A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors