A Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Clinical Activity of TUB-040, in Combination With Standard Ovarian Cancer Drugs in Patients With High-grade Epithelial Serous or Endometrioid Epithelial Ovarian Cancer OC)
Tubulis GmbH
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Female ≥ 18 years of age at the time of the first screening visit 2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 3. Histologically confirmed advanced high-grade serous or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer. 4. 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…