Tubulis GmbH
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.
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…
Ph1b: A complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered along with carboplatin (Carbo) and bevacizumab (BEV) as an intravenous (IV) solution on day 1 of each treatment cycle for up to 6 cycles.