The goal of this clinical study is to learn more about the study drug TUB-040, safety, tolerability, pharmacokinetics (PK), and effectiveness in treating patients with recurrent or progressive uterine endometrial cancer after platinum-based chemotherapy and immune checkpoint inhibitor therapy.
The primary objectives of Phase 1 of this study are to determine the safety and tolerability of TUB-040 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D).
The primary objective of Phase 2 of this study is to evaluate the efficacy of TUB-040 monotherapy at the RP2D in endometrial cancer.
Histologically confirmed advanced recurrent or progressive serous or endometroid endometrial cancer.
Pathological report with results of institutional MMR and/or MSI testing.
Radiographic progression on or after the most recent line of anticancer therapy.
Female aged ≥ 18 years at the time of consent.
Unresolved bowel obstruction, including radiographic findings consistent with bowel obstruction plus clinical signs and symptoms of obstruction such as nausea and/or vomiting.
Prior thoracocentesis for therapeutic drainage of malignant effusion within 4 weeks prior to initiation of study treatment.
Paracentesis for therapeutic drainage of malignant effusion within 4 weeks prior to initiation of study treatment.
Receiving total parenteral nutrition.