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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
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
Where Is This Study? (6 UK sites)
Royal United Hospitals NHS Foundation Trust
Bath BA1 3NG, United Kingdom
St James's University Hospital
Leeds LS9 7TF, United Kingdom
Royal Marsden Hospital (Sutton)
London SM2 5PT, United Kingdom
Royal Marsden Hospital (Chelsea)
London SW3 6JJ, United Kingdom
The Christie NHS Foundation Trust
Manchester M20 4BX, United Kingdom
Torbay Hospital
Torquay TQ2 7AA, United Kingdom
How to Get in Touch
Trial questions or participation questions 1-877-CTLILLY (1-877-285-4559) or
Sponsor contactCONTACT
Physicians interested in becoming principal investigators please contact
Sponsor contactCONTACT
