Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer (NCT07637851) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Safety and Efficacy of Ubamatamab With First-line Chemotherapy in Ovarian Cancer
France43 participantsStarted 2026-08
Plain-language summary
The purpose of this clinical trial is to assess the safety and efficacy of ubamatamab in combination with first-line chemotherapy in patients with ovarian cancer. The main questions it aims to answer are:
* What is the safety profile of ubamatamab when administered with carboplatin-paclitaxel ± bevacizumab?
* What is the objective response rate after three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab?
Participants will:
* Receive three cycles of ubamatamab in combination with carboplatin-paclitaxel ± bevacizumab, followed by maintenance therapy with ubamatamab ± bevacizumab for up to 15 months, depending on HRD status and disease response after the initial treatment cycles.
* Attend regular clinic visits throughout the treatment period for checkups and tests
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed high-grade epithelial (serous, endometrioid, or carcinosarcoma with a ≥30% epithelial tumor component) ovarian, primary peritoneal, or fallopian-tube carcinoma
. Adult patient aged ≥ 18 years old
. Advanced stage III or IV
. Treated with 3 or 4 standard neo-adjuvant cycles of carboplatin-paclitaxel regimen, in first line, given every 3 weeks, and characterized by 2 unfavorable features (both are required):
. Disease measurable and assessable by imaging based on RECIST 1.1 criteria (thorax-abdomen-pelvis CT-scanner; FDG-PET-CT-scanner; and/or MRI)
. Availability of a tumor tissue for translational research (archival tissue, or alternatively from fresh biopsy, and/or surgery)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period
Timeframe: Up to 4 weeks of treatment
2
Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period
Timeframe: Up to 4 weeks of treatment
3
Safety run-in phase I : Safety and recommended dose for phase II trial during the Dose-limiting toxicities monitoring period
Timeframe: From Cycle 1 Day 1 of the first patient included to Cycle 3 Day 1 of the sixth patient included (each cycle is 21 days) (Safety and Tolerability)
4
Efficacy phase II part
Timeframe: 1 month after Cycle 3 Day 1 of the sixth patient included (each cycle is 21 days).
. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
. BRCA and HRD status known, or planned during the trial (before maintenance treatment)
Exclusion criteria
6. Uncontrolled infection with human immunodeficiency virus, hepatitis B or hepatitis C infection; or diagnosis of immunodeficiency or known latent tuberculosis infection.
7. Other active infections requiring hospitalization or IV anti-infectives within 2 weeks before starting study treatment.
8. Receipt of a live vaccine within 30 days of planned start of study medication.
9. Pregnant or lactating patients or patients expecting to conceive children within the projected duration of the trial.
0. Women of childbearing potential (WOCBP)\* who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose. Highly effective contraceptive measures include:
. stable use of combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) or progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation initiated 2 or more menstrual cycles prior to screening
. intrauterine device (IUD); intrauterine hormone-releasing system (IUS)