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.
Sequential
TUB-040 - Dose escalation
DrugTUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle.
TUB-040 - RP2D
DrugTUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle. Dose based on the RP2D
Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
Incidence of dose-limiting toxicities (DLTs) at each dose level
Phase 2: Overall Response Rate (ORR)
Investigator (INV) assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Phase 1: Overall Response Rate (ORR)
Investigator (INV) assessment of overall response rate (ORR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Phase 1: Duration of Response (DOR)
Investigator (INV) assessment of duration of response (DOR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Phase 1: Progression-Free Survival (PFS)
Investigator (INV) assessment of progression-free survival (PFS) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
Phase 1: Disease Control Rate (DCR)
Investigator (INV) assessment of disease control rate (DCR) by Response Evaluation Criteria for Solid Tumors (RECIST) v1.1
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