A Multicenter Phase 1/2 Study to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of the NaPi2B Antibody-Drug Conjugate TUB-040 in Patients With Recurrent or Progressive Uterine Endometrial Cancer After Platinum-Based Chemotherapy and Immune Checkpoint Inhibitor Therapy
Tubulis GmbH
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: 1. Histologically confirmed advanced recurrent or progressive serous or endometroid endometrial cancer. Note: Mixed histologies are allowed if the dominant subtype is serous or endometroid. 2. Pathological report with results of institutional MMR and/or MSI testing. 3. Received at least 1 but no more than 3 prior lines of anticancer therapy: a. Must have received at least 1 line of platinum-based therapy and 1 line of programmed death ligand-1 inhibitor therapy (separately or in combination) Note: Patients who were unable to receive immunotherapy for a medical reas…