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
- Raludotatug Deruxtecan (biological), Carboplatin (drug), Paclitaxel (drug), Bevacizumab (biological)
- How long the study runs
- Study runs about 70 months (dates as stated)
- About the drug or intervention
- Raludotatug Deruxtecan — biological: IV infusion on Day 1 of every 3-week cycle. · Carboplatin — drug: IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles. · Paclitaxel — drug: IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles. · Bevacizumab — biological: IV infusion on Day 1 of every 3-week cycle. · Rescue Medication — drug: Includes 5-HT3 Serotonin Receptor Antagonist, NK-1 receptor antagonist, and corticosteroid, administered per protocol. · Pembrolizumab — biological: IV infusion on Day 1 of every 3-week cycle for a maximum of 35 cycles. · Gemcitabine — drug: IV injection on days 1 and 8 of each 3-week Cycle · Pegylated liposomal doxorubicin — drug: IV injection administered on Day 1 of each 4-week cycle · MK-2010 — drug: IV infusion on Day 1 of every 3-week cycle
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 605
- Started
- 2025-04-15
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for ovarian cancer recurrent
- • Phase1/Phase2 - 605 participants
- • Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with ovarian cancer recurrent
- • Female only
Where?
- • Brighton - University Hospitals Sussex NHS Foundation Trust ( Site 0404)
- • Fulham - Royal Marsden Hospital ( Site 0402)
- • Sutton - The Royal Marsden NHS Foundation Trust. ( Site 0403)
- • London - Barts Health NHS Trust ( Site 0401)
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Researchers are looking for other ways to treat high-grade serous and certain other ovarian cancer. High-grade means the cancer cells grow and spread quickly. Serous means the cancer started in the cells that cover the ovaries, the lining of the belly, or in the fallopian tubes. Standard treatment (usual treatment) for people with high-grade serous ovarian cancer may include: * Chemotherapy, which is a treatment that uses medicine to destroy cancer cells or stop them from growing * Targeted therapy, which is a treatment that works to control how specific types of cancer cells grow and spread Raludotatug deruxtecan (R-DXd) is a study treatment that is an antibody drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells. Researchers want to know if R-DXd is safe to take with other treatments and if people tolerate them together. They also want to learn how many people have the cancer respond (gets smaller or goes away) to the treatments.
More detail
This study has 2 parts: Part 1 is a dose escalation phase of R-DXd. Part 2 is the expansion phase and will use the Recommended Phase 2 Dose (RP2D) of R-DXd determined in Part 1.
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: Female only
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ received no more than 1 prior bevacizumab-containing systemic treatment regimen
- ✓ of therapy
What the study is looking for
- ✓Has pathologically documented diagnosis of high-grade serous or high-grade endometrioid epithelial ovarian cancer,...
- ✓Participants in Part 1 cohorts and Part 2 Cohort A-2 Arms 1, 2, and 3, Cohort B-2, and Cohort C-2 Arm 3: Has...
- ✓Participants in Cohort B-1, Cohort B-2, Cohort C-2 Arm 3, Cohort E-1 and if administering bevacizumab is planned in...
- ✓Has provided tumor tissue for test result research (all cohorts)
- ✓Has an activity scale performance status of 0 to 1
Who cannot take part
- ✗Has any of the following within 6 months before allocation/randomization: cerebrovascular accident, transient...
- ✗Has uncontrolled or significant cardiovascular disease
- ✗Has ≥Grade 2 peripheral neuropathy
- ✗Has received prior treatment with cadherin-6-targeted agents
- ✗Has received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives...
See the full criteria
Where Is This Study? (6 UK sites)
University Hospitals Sussex NHS Foundation Trust ( Site 0404)
Brighton BN2 1ES, United Kingdom
Royal Marsden Hospital ( Site 0402)
Fulham SW3 6JJ, United Kingdom
The Royal Marsden NHS Foundation Trust. ( Site 0403)
Sutton SM2 5PT, United Kingdom
Barts Health NHS Trust ( Site 0401)
London E1 1RD, United Kingdom
Guy s & St Thomas NHS Foundation Trust ( Site 0400)
London SE1 3SS, United Kingdom
The Christie NHS Foundation Trust ( Site 0405)
Manchester M20 4BX, United Kingdom
How to Get in Touch
Toll Free Number
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