Study of TUB-040 Given With Standard Ovarian Cancer Drugs in Patients With Fast-growing Ovarian Cancer (NCT07736937)
π©Ί Plain-English Summary (8th-Grade Level)
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 join: To join this study, participants generally need to meet the listed inclusion criteria (34 items) and avoid the listed exclusions (29 items).
Location: Start Cal β Los Angeles, California
π "Do I Qualify?" β 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- Previous systemic topoisomerase-1 inhibitor treatment (except Topotecan)
- History of hypersensitivity to monoclonal antibodies, exatecan or excipients of the TUB-040 formulation. Note: The excipients of TUB-040 are listed in the IB.
- 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)
- Patients with serum albumin level \<2,5 g/dL (subjects should not have received IV albumin within 4 weeks of the test)
- Participation in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives (whichever is shorter) of any investigational pharmacologic agents before study treatment
- Patients with untreated spinal cord compression or cerebrovascular accident/stroke within \<6 months of enrollment
π Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
π All Participating Trial Locations (8 Sites)
- Start Cal β Los Angeles, California
- Start Njeb β East Brunswick, New Jersey
- Start Nyli β New York, New York
- UCL Louvain β Brussels,
- UZ Gent β Ghent,
- UZ Leuven β Leuven,
- CHU de Liege β LiΓ¨ge,
- ARENSIA Exploratory Medicine β Kyiv,
π° Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA Β§ 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.