Study of TUB-040 with Standard Ovarian Cancer Drugs for Fast-growing Ovarian Cancer
Sponsor: Tubulis GmbH
ClinicalTrials ID:NCT07736937
This clinical trial is exploring the safety and effectiveness of a new drug, TUB-040, when used with standard treatments for patients with aggressive ovarian cancer. The study aims to find the best dose of TUB-040 when combined with carboplatin and bevacizumab.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate how safe and effective TUB-040 is when given with standard ovarian cancer treatments, specifically for patients with high-grade serous or endometrioid ovarian cancer. Researchers are also determining the best dose of TUB-040 to use alongside carboplatin and bevacizumab, especially for those whose cancer is sensitive to platinum-based treatments.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 or older.
- Good overall health with an ECOG performance status of 0 or 1.
- Diagnosed with advanced high-grade serous or endometrioid ovarian, fallopian tube, or primary peritoneal cancer.
- Cancer that has responded to platinum-based treatments and has not worsened within 6 months after the last treatment.
- At least one tumor that can be measured by scans.
- Cancer must have shown progression on or after the most recent treatment.
- Adequate blood cell counts and liver and kidney function.
- Willing to provide a tumor sample for research purposes.
- Resolved side effects from previous treatments to a mild level.
- Completed a washout period after previous treatments.
- Women of childbearing potential must use effective contraception during the study and for a specified period after.
- Must have had 1-2 prior lines of platinum therapy without progression within 182 days after the last dose.
- Prior treatment with PARP inhibitors if applicable.
Exclusion Criteria
- Certain types of ovarian cancer, such as clear-cell or mucinous.
- Cancer that did not respond to or worsened quickly after platinum-based treatments.
- Pregnant or breastfeeding women.
- History of severe allergic reactions to study drugs.
- Unresolved bowel obstruction or certain abdominal conditions.
- Recent major surgery or other clinical trial participation.
- Certain lung or heart conditions.
- Active infections or other serious health issues.
- Recent use of live vaccines.
- History of severe blood clots or uncontrolled high blood pressure.
- Requirement to take certain medications that interact with the study drugs.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Start Cal | 90025 | Los Angeles | California |
| Start Njeb | 08816 | East Brunswick | New Jersey |
| Start Nyli | 11042 | New York | New York |
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