Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian C… (NCT07736937) | Clinical Trial Compass
RecruitingPhase 1/2
Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer
United States, Belgium, Ukraine72 participantsStarted 2026-03-30
Plain-language summary
The goal of this clinical study is to learn more about the safety, tolerability, and preliminary effectiveness of TUB-040 when given in combination with standard ovarian cancer treatments in participants with high-grade epithelial serous or endometrioid ovarian cancer.
This study will also evaluate the appropriate dose of TUB-040 when used with carboplatin (Carbo) and bevacizumab (BEV), including determining the maximum tolerated dose (MTD) in participants with platinum-sensitive ovarian cancer.
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
. Female ≥ 18 years of age at the time of the first screening visit
. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
. Histologically confirmed advanced high-grade serous or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer.
. Have platinum-sensitive ovarian cancer (PSOC) defined as: Patients who had recurrences (radiologically confirmed) to platinum-based therapy and have responded to the last platinum therapy received before study entry and did not progress within 6 months (182 days) of the date of the last dose of platinum-based systemic treatment.
. Radiologically measurable disease in at least 1 lesion by Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, that can include a lesion in an irradiated field and that shows progression according to RECIST v1.1
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
To determine the safety and tolerability of TUB-040 in combination with standard ovarian cancer drugs
Timeframe: From enrollment until 30 days after last study drug
2
Maximum Tolerated Dose (MTD) of TUB-040 with standard of care (SOC) treatment
Timeframe: Day 1 up to Day 21 of each treatment cycle
. Patients must have progressed radiographically on or after their most recent line of anticancer therapy
. Adequate hematologic function as indicated by:
. Platelet counts ≥100,000/mm3 (no transfusion or growth factors, e.g., eltrombopag, romiplostim, or IL-11 within 4 weeks before first dose)
Exclusion criteria
. Patients with clear-cell, mucinous histology, mixed histology with mucinous component, sarcoma, sarcomatous component, or low-grade ovarian cancer
. Patients with platinum refractory ovarian cancer (OC) (Platinum refractory is defined as disease that has not responded to a primary platinum-based regimen or progressed within 30 days after primary platinum-based therapy) or platinum resistant ovarian cancer
. Patient pregnant, lactating or breastfeeding or having a positive serum pregnancy test during the screening period
. History of hypersensitivity to monoclonal antibodies, exatecan or excipients of the TUB-040 formulation.
. Patients with unresolved malignant bowel obstruction (including patients with radiological findings indicating possible bowel obstruction on CT scans), history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess or Patients on total parenteral nutrition (TPN)
. Prior thoracocentesis for therapeutic drainage of malignant effusion \< 4 weeks from trial inclusion and repeated paracentesis for therapeutic drainage of malignant effusion \< 4 weeks before trial inclusion
. Prior radiotherapy to the pelvis or abdomen (Dose Escalation phase only)