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Looking for participantsPhase3

A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer

Sponsor: Eli Lilly and Company

NCT ID: NCT07213804

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sofetabart Mipitecan (drug), Paclitaxel (drug), Topotecan (drug), Gemcitabine (drug)
How long the study runs
Study runs about 70 months (dates as stated)
About the drug or intervention
Sofetabart Mipitecan — drug: Administered IV · Paclitaxel — drug: Administered IV · Topotecan — drug: Administered IV · Gemcitabine — drug: Administered IV · Pegylated liposomal doxorubicin (PLD) — drug: Administered IV · MIRV — drug: Administered IV · Bevacizumab — drug: Administered IV · Carboplatin — drug: Administered IV
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,630
Started
2025-10-22
Last checked
2026-10

Plain English Summary

What is this study?

  • • Testing a new treatment for ovarian neoplasms
  • • Phase3 - 1,630 participants
  • • This is a clinical study that has three parts

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with ovarian neoplasms

Where?

  • • Bath - Royal United Hospitals NHS Foundation Trust
  • • Leeds - St James's University Hospital
  • • London - Royal Marsden Hospital (Sutton)
  • • London - Royal Marsden Hospital (Chelsea)
  • • +2 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.

Ovarian NeoplasmsFallopian Tube NeoplasmsPeritoneal NeoplasmsNeoplasm Metastasis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Biomarkers mentioned

BRCA1

What the study is looking for

  • ✓Part A, B, and C:
  • ✓Have confirmed by a biopsy 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 activity scale (ECOG) performance status of 0-1.

Who cannot take part

  • ✗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...
  • ✗Part B and C:
See the full criteria
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).

Where Is This Study? (6 UK sites)

Royal United Hospitals NHS Foundation Trust

Bath BA1 3NG, United Kingdom

Recruiting
Site contact (verified)
Rebecca BowenPrincipal Investigator

St James's University Hospital

Leeds LS9 7TF, United Kingdom

Recruiting
Site contact (verified)
David JacksonPrincipal Investigator

Royal Marsden Hospital (Sutton)

London SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Susana BanerjeePrincipal Investigator

Royal Marsden Hospital (Chelsea)

London SW3 6JJ, United Kingdom

Recruiting
Site contact (verified)
Susana BanerjeePrincipal Investigator

The Christie NHS Foundation Trust

Manchester M20 4BX, United Kingdom

Recruiting
Site contact (verified)
Andrew ClampPrincipal Investigator

Torbay Hospital

Torquay TQ2 7AA, United Kingdom

Recruiting
Site contact (verified)
Nangi LoPrincipal Investigator

How to Get in Touch

Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or

Sponsor contact

CONTACT

1-317-615-4559 LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

Sponsor contact

CONTACT

clinical_inquiry_hub@lilly.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-10