Phase 3 study for people with Ovarian Cancer

Recruiting Phase 3

Sources: ClinicalTrials.gov Checked: 15 October 2026 Not medical advice

This trial at a glance

Status Recruiting

Phase Phase 3

Sponsor Eli Lilly and Company

Registry number NCT07213804

Started 22 October 2025 Today 16 October 2026 Estimated completion 1 November 2028

Where this trial is running

Trial sites and the status recorded for each
Site	City	State or country	Status at this site
Ballarat Health Services	Ballarat Central	VIC	Recruiting
Chris O'Brien Lifehouse	Camperdown	NSW	Recruiting
Launceston General Hospital	Launceston	TAS	Recruiting
Cabrini Hospital - Malvern	Malvern	VIC	Recruiting
Prince of Wales Hospital	Randwick	NSW	Recruiting
Goulburn Valley Health	Shepparton	VIC	Recruiting
Gold Coast University Hospital	Southport	QLD	Not yet recruiting
Royal North Shore Hospital	St Leonards	NSW	Recruiting
The Townsville Hospital	Townsville	QLD	Recruiting
Latrobe Regional Health	Traralgon	VIC	Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 15 October 2026 · not medical advice

Who can join

Age 18 Years and over

Sex Anyone, regardless of sex

Healthy volunteers Not accepted

Enrolment target 1630

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

Part A, B, and C:

* Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.

* Have confirmed availability of tumor tissue block or slides

* Have radiographic progression on or after most recent line of systemic anticancer therapy

* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

* Have measurable disease per RECIST v1.1

Part A:

* Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.

* Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.

* Have received prior bevacizumab treatment, unless documented contraindication or intolerance.

* Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.

Part B and C:

* Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (\>)6 months of their last administration of platinum therapy

* Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy

Part B:

\- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.

Part C:

\- Have not previously received a PARPi treatment.

Exclusion Criteria:

Parts A, B and C:

\- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.

Part A:

* Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.

Part B and C:

\- Have clinically significant proteinuria

Part C:

\- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).

Dates on the record

Started 22 October 2025

Estimated completion 1 November 2028

Registry last updated 8 October 2026

Checked by Voxsanity 15 October 2026

Results, publications and the official record

No results are posted on the official record yet.
No publications are listed on the official record yet.
Official record and contacts on ClinicalTrials.gov – contact details for each site are kept there, and are not copied onto this page.

Sources and dates

ClinicalTrials.gov – the record this page reformats
ClinicalTrials.gov processing date: 8 October 2026.
This page last checked by Voxsanity: 15 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.

Voxsanity

Clinical trials recruiting in Australia, from the public registries · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial, which may be relevant to my care:

Trial: NCT07213804

Sponsor: Eli Lilly and Company

Phase: Phase 3

Status: Recruiting

Condition: Ovarian Cancer

More information: https://clinicaltrials.gov/study/NCT07213804

Eligibility criteria, as the registry published them

Reproduced exactly, unedited. Written for researchers rather than for patients.

Inclusion Criteria:

Part A, B, and C:

Have histologically confirmed high-grade serous or endometrioid ovarian, primary peritoneal, or fallopian tube cancer.
Have confirmed availability of tumor tissue block or slides
Have radiographic progression on or after most recent line of systemic anticancer therapy
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Have measurable disease per RECIST v1.1

Part A:

Have platinum-resistant disease, defined as radiographic progression less than or equal to (≤)6 months of the last administration of platinum therapy.
Have previously received 1 to 3 prior lines of systemic cytotoxic therapy. Up to 4 lines of prior cytotoxic therapy is allowed if one of those lines is mirvetuximab soravtansine.
Have received prior bevacizumab treatment, unless documented contraindication or intolerance.
Have received treatment with a poly (ADP-ribose) polymerase inhibitor (PARPi) if known to have a somatic or germline breast cancer gene (BRCA) mutation, if clinically indicated, unless documented contraindication or intolerance.

Part B and C:

Have relapsed after first-line platinum-based chemotherapy and have platinum-sensitive disease defined as radiographic progression greater than (>)6 months of their last administration of platinum therapy
Have previously received 1 to 2 prior lines of systemic cytotoxic chemotherapy

Part B:

- Have previously received a PARPi, per local product label, with progression on, or within 6 months of completion of PARPi treatment.

Part C:

- Have not previously received a PARPi treatment.

Exclusion Criteria:

Parts A, B and C:

- Have received prior antibody-drug conjugate (ADC) with a topoisomerase inhibitor payload.

Part A:

Have primary platinum-refractory disease, defined as radiographic progression ≤ 1 month since the last dose of first-line platinum-containing chemotherapy.

Part B and C:

- Have clinically significant proteinuria

Part C:

- Have a known pathogenic BRCA1/2 gene alteration (somatic or germline).

A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a registered health practitioner to access unapproved therapeutic goods for individual patients.

Not medical advice. Voxsanity reformats information published by public registries. It does not give medical advice and is not a substitute for talking to your doctor.