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.
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.
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)
Sequential
TUB-040 + Carbo + BEV
DrugPh1b: 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.
To determine the safety and tolerability of TUB-040 in combination with standard ovarian cancer drugs
Occurrence and severity of treatment-emergent adverse events (TEAEs)
Maximum Tolerated Dose (MTD) of TUB-040 with standard of care (SOC) treatment
Occurrence of DLTs (Dose limiting toxicities) at different dose levels (during first treatment cycle)
PK Characterization of TUB-040: Cmax
PK parameters of TUB-040 ADC including maximum concentration Cmax
PK Characterization of TUB-040: Tmax
PK parameters of TUB-040 ADC including time to Cmax (Tmax)
PK Characterization of TUB-040: AUC
PK parameters of TUB-040 ADC including area under the curve (AUC)
PK Characterization of TUB-040: t1/2
PK parameters of TUB-040 ADC including as far as collected data allow an estimation of half-life (t1/2)
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