AstraZeneca registers Phase 3 ovarian cancer ADC trial and Phase 1 hMPV antibody study

AstraZeneca had three new clinical trial registry entries post this week, none yet recruiting or recruiting participants.

• Torvutatug samrotecan (AZD5335), a folate receptor alpha-targeting antibody-drug conjugate, moved into a Phase 3 trial called TREVI-OC-03, testing the drug with or without bevacizumab against standard of care as maintenance therapy in platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer. The study is designed to measure efficacy and safety of torvutatug samrotecan with or without bevacizumab compared to standard of care as maintenance treatment in participants with platinum-sensitive relapsed ovarian cancer.¹ The trial is not yet recruiting, with an estimated enrollment of 600 participants and progression-free survival as the primary outcome, assessed by Blinded Independent Central Review over approximately 5 years.¹
• AZD0543, a biological agent, entered a Phase 1 randomized, placebo-controlled study in healthy adults to assess safety and pharmacokinetics ahead of use in preventing human metapneumovirus infection. The dose-escalation study will randomize 144 participants to one of three dose levels of AZD0543 or a volume-matched placebo.² The study is recruiting, with primary completion estimated for March 2027.
• AstraZeneca is a funding collaborator, not the sponsor, on an Italian observational study of HRD testing in newly diagnosed advanced ovarian cancer led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The multicenter, retrospective, non-profit study, co-funded by AstraZeneca, plans to enroll 1125 advanced-stage high-grade epithelial ovarian cancer patients who underwent HRD testing across seven centers.³ The study is not yet recruiting.