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

NCT07743541 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-05

No results posted yet for this study

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.

Conditions

  • Uterine Endometrial Cancer

Interventions

DRUG

TUB-040 - Dose escalation

TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle.

DRUG

TUB-040 - RP2D

TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle. Dose based on the RP2D

Sponsors & Collaborators

  • Tubulis GmbH

    lead INDUSTRY

Principal Investigators

  • Tubulis Medical Director · Tubulis GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-09-30
Completion
2029-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07743541 on ClinicalTrials.gov