About this trial
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 criteria
Qualifiers
Female ≥ 18 years of age at the time of the first screening visit
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
Histologically confirmed advanced high-grade serous or endometrioid epithelial ovarian, fallopian tube or primary peritoneal cancer.
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 platinum-based systemic treatment.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- TUB-040 + Carbo + BEV