NCT07402915

Drug-drug Interaction Study With AZD5335 and Itraconazole in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

An Open-label, Fixed Sequence Phase I Study to Evaluate the Effect of Itraconazole (a Strong CYP3A Inhibitor) on the Pharmacokinetics of AZ14170132, the TOP1 Inhibitor Payload of the Antibody Drug Conjugate AZD5335, in Participants With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effect of itraconazole on the pharmacokinetics (PK) of AZ14170132.

Detailed description

This is a non-randomized, open-label, fixed sequence study to be conducted at multiple study centers. The study will consist of 2 parts: Part A of the study will comprise of: * Screening period * Treatment period: The treatment period will comprise of Cycles 1, 2 and 3 where the participants will receive AZD5335 along with itraconazole * Follow-up visit (not applicable for participants involved in Part B) Part B of the study will comprise of: * Treatment period: Cycle 4 and onwards * Safety Follow-up period

Conditions

• Fallopian Tube Cancer
• Ovarian Cancer
• Primary Peritoneal

Interventions

Type	Name	Description
DRUG	AZD5335	AZD5335 will be administered as IV infusion.
DRUG	Itraconazole	Itraconazole capsule will be administered orally.

Timeline

• Start date: 2026-01-26
• Primary completion: 2027-10-15
• Completion: 2027-10-15
• First posted: 2026-02-11
• Last updated: 2026-04-02

Locations

9 sites across 4 countries: Georgia, Ireland, Portugal, Spain