Study of TUB-040 with Standard Ovarian Cancer Drugs for Fast-growing Ovarian Cancer

Sponsor: Tubulis GmbH

Sponsor score: 0

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

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

FACILITYZIPCITYSTATE
Start Cal90025Los AngelesCalifornia
Start Njeb08816East BrunswickNew Jersey
Start Nyli11042New YorkNew York

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