AZD5335 given with itraconazole for ovarian, fallopian tube, and primary peritoneal 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

This trial will test whether the antifungal itraconazole changes how the investigational drug AZD5335 is processed in the body for people with platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: AstraZeneca (Industry-sponsored)
• Drugs / interventions: bevacizumab, chemotherapy
• Locations: 9 sites (Batumi and 8 other locations)
• Trial ID: NCT07402915 on ClinicalTrials.gov

What this trial studies

This is an open-label, non-randomized, fixed-sequence Phase 1 study that examines the pharmacokinetic interaction between AZD5335 and the strong CYP3A inhibitor itraconazole. Part A includes screening and three treatment cycles during which participants receive AZD5335 together with itraconazole; Part B covers later treatment cycles and safety follow-up. The study enrolls adults with platinum-resistant, relapsed high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who meet protocol safety criteria. Pharmacokinetic sampling and safety assessments will be used to determine how itraconazole affects AZD5335 exposure.

Who should consider this trial

Good fit: Ideal candidates are adults with platinum-resistant, relapsed high‑grade epithelial ovarian, primary peritoneal, or fallopian tube cancer who have had at least one prior platinum-containing chemotherapy line, appropriate prior bevacizumab/PARP exposure per local guidance, and an ECOG performance status of 0 or 1.

Not a fit: Patients with unresolved Grade ≥2 toxicities from prior therapy, known interstitial lung disease/pneumonitis requiring steroids or oxygen, spinal cord compression or leptomeningeal carcinomatosis, or those who do not meet the platinum-resistant criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, results could guide safer dosing when AZD5335 is given with itraconazole or other CYP3A inhibitors, reducing unexpected side effects or underexposure.

How similar studies have performed: Using itraconazole as a prototypical strong CYP3A inhibitor to define drug–drug interactions is a well-established and standard approach, though the specific interaction with AZD5335 is novel and untested.

Eligibility criteria

Inclusion Criteria:

* Participants with Platinum-resistant, relapsed, high- grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer and: (a) have received at least 1 prior line of platinum-containing chemotherapy and have progressed on or within 6 months after the date of the last dose of platinum; (b) must have received prior bevacizumab and/or Poly (ADP-ribose) polymerase (PARP) inhibitors according to local guidelines, unless ineligible.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion Criteria:

* Spinal cord compression or a history of leptomeningeal carcinomatosis.
* Unresolved toxicities of Grade ≥ 2 (National Cancer Institute-Common Terminology Criteria for Adverse Events v5.0) from prior therapy.
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
* Uncontrolled intercurrent illness within 12 months prior to screening.
* Any other contraindication for receiving itraconazole according to the prescribing information and the Investigator.

Where this trial is running

Batumi and 8 other locations

• Research Site — Batumi, Georgia (Not_yet_recruiting)
• Research Site — Tbilisi, Georgia (Not_yet_recruiting)
• Research Site — Tbilisi, Georgia (Not_yet_recruiting)
• Research Site — Dublin, Ireland (Recruiting)
• Research Site — Lisbon, Portugal (Recruiting)
• Research Site — Barcelona, Spain (Recruiting)
• Research Site — Logroño, Spain (Recruiting)
• Research Site — Madrid, Spain (Recruiting)
• Research Site — Madrid, Spain (Recruiting)

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal; CYP3A inhibitor; TOP1 inhibitor payload