Clinical Trial

Study of TUB-040 in Patients With Recurrent or Progressive Uterine Cancer After Chemotherapy and Immune Therapy

Study acronym: NAPISTAR 1-03
Not Yet Recruiting Phase 1/2
View on ClinicalTrials.gov →
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.
Trial Details
NCT Number NCT07743541
Lead Sponsor Tubulis GmbH
Conditions Uterine Endometrial Cancer
Enrollment 100 participants
Start Date 2026-10
Primary Completion 2029-09 (estimated)
Study Completion 2029-09 (estimated)
Updated on ClinicalTrials.gov 2026-08-05