OVARIAN: PLATINUM RESISTANT: POST-1st line: TREVI-OC-01

Study snapshot

Title: Astra Zeneca D8991C00001 AZD5335 Plat Resist Ovarian
Malignancy: Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer
Stage: Stage 4
Disease setting: Metastatic/Palliative
Line of therapy: 2nd or higher
Investigational agent: AZD5335
Drug class: Folate receptor alpha ADC
Principal investigator: Michael Ulm, MD
Sponsor: AstraZeneca
Path: Epithelial
Randomized: Yes
ClinicalTrials.gov ID: NCT07218809

Key Inclusion criteria

Participants with confirmed diagnosis of high-grade serous EOC, primary peritoneal cancer, or fallopian tube cancer.
Participants must have platinum-resistant disease:
Participants who have only had one prior line of platinum-based therapy must have received at least 4 cycles of platinum, must have had a response (CR or PR) and then progressed between > 3 months and ≤ 6 months after the date of the last dose of platinum.
Participants who have received 2 or 3 lines of platinum therapy must have progressed ≤ 6 months after the date of the last dose of platinum.
Participants must have radiologically progressed on or after their most recent line of therapy.
Participants must have received at least one, but no more than 3, prior systemic lines of anti-cancer therapy, and for whom single-agent therapy is appropriate as the next line of treatment
Participants with documented BRCA mutation (germline and/or somatic) must have received prior PARPi if the participant is eligible per approved label and standard-of-care institutional guidelines, except in cases of documented contraindication, precaution or intolerance.
Provision of an FFPE tumour tissue sample

Key Exclusion criteria

Participants with endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumours containing any of the above histologies, or low-grade or borderline ovarian tumour.
Primary platinum-refractory disease, defined as disease that did not respond to or has progressed ≤ 3 months after the last dose of first line platinum-containing chemotherapy.
Participants with active or chronic corneal disorders, history of corneal transplantation, or active ocular conditions requiring ongoing treatment/monitoring
Current signs, symptoms, or clinical investigations consistent with bowel obstruction, including sub-occlusive disease.
Participant has non-infectious ILD/pneumonitis or has a history of non-infectious ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
Prior treatment with any FRα-targeted therapy, including MIRV, or any TOP1i ADC.
Major surgical procedure within 4 weeks of the first dose of study intervention