NCT07059845
Who may be able to join
Who might be able to join this trial:
All parts of the trial require:
- You must be willing to provide a stored tumor tissue sample or agree to a new tumor biopsy (using a low-risk, routine procedure) so that the tumor can be tested for a specific protein called FRα — and at least half of your tumor cells must show a strong enough level of this protein.
- You must be generally well enough to carry out light activity and care for yourself (your doctor will assess this using a standard scale — scoring 0 or 1 out of 4).
Part 1 (Substudy 1) also requires:
- If starting first-line treatment: you must have a confirmed diagnosis of advanced (Stage III or IV) high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- If starting second-line treatment: your cancer must be the platinum-sensitive type, meaning it came back more than 6 months after your last platinum-based chemotherapy ended.
- You must have an available genetic test result showing whether your cancer has certain gene changes (BRCA or HRD status) — your doctor can explain what this means for you.
Parts 2 and 3 (Substudies 2 & 3) also require:
- You must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.
- Your cancer must have come back after 1 or 2 previous rounds of platinum-based chemotherapy.
- Your cancer must be the platinum-sensitive type, meaning it returned more than 6 months after your last platinum-based chemotherapy ended.
- Your cancer must be measurable on a scan at the time of joining the trial.
Who may not be able to join:
Part 1 (Substudy 1):
- Your cancer got worse while on, or shortly after finishing, your most recent triple-drug treatment course (before joining the trial).
- You received an extra dose of a drug called bevacizumab after your last treatment cycle and before joining the trial.
- You have previously been treated with a drug called mirvetuximab soravtansine, any other treatment that targets the FRα protein, or a type of drug known as a PARP inhibitor.
Parts 2 and 3 (Substudies 2 & 3):
- You have received more than 2 separate courses ("lines") of chemotherapy in the past (confirm with trial site for how your specific treatments are counted, as maintenance therapies and some combined treatments may be counted differently).
- You have previously been treated with mirvetuximab soravtansine or any other treatment that targets the FRα protein.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Trial details
Where this trial is recruiting
10 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Substudy 1, 2, and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) (any grade, Grade >= 3); Substudy 1, 2, and 3: Number of Participants with TEAEs Leading to Discontinuation; Substudy 1, 2, and 3: Number of Participants with Ocular Adverse Events (AEs) (any grade, Grade >= 2); Substudy 1, 2, and 3: Overall Response (OR) as Assessed by the Investigator per RECIST v1.1; Substudy 1: Progression free survival (PFS) as Assessed by the Investigator per RECIST v1.1
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.