Study of TUB-040 in Patients With Recurrent or Progressive Uterine Cancer After Chemotherapy and … (NCT07743541) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Study of TUB-040 in Patients With Recurrent or Progressive Uterine Cancer After Chemotherapy and Immune Therapy
United States100 participantsStarted 2026-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed advanced recurrent or progressive serous or endometroid endometrial cancer.
. Pathological report with results of institutional MMR and/or MSI testing.
. Received at least 1 but no more than 3 prior lines of anticancer therapy:
. Radiographic progression on or after the most recent line of anticancer therapy.
. Female aged ≥ 18 years at the time of consent.
. Disease not amenable to curative intent treatment.
. Radiologically measurable disease by RECIST v1.1, which can include a lesion in an irradiated field that showed progression by RECIST v1.1 after irradiation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since TUB-040 is a Phase 1/Phase 2 trial that hasn't started enrolling patients yet, what does that mean for how much safety data will be available by the time I might be considered, and how does that uncertainty compare to my other options right now?
2The Phase 1 part of this trial is specifically measuring dose-limiting toxicities — meaning researchers are still figuring out the safest dose — so what kinds of side effects would you want me to watch for, and how would my history with prior chemotherapy and immunotherapy affect my risk?
3This trial is designed for uterine cancer that has come back or kept growing after both chemotherapy and immune therapy, which matches my situation — but are there other treatments or trials you'd recommend I consider first before a study still in its earliest phase?
4Since the trial isn't recruiting yet, how long do you think it might be before it opens, and given how quickly my cancer has been progressing, is waiting a realistic option for me?
5The Phase 2 portion will measure overall response rate, meaning how many patients' tumors shrink — but since we don't have those results yet, what would you use to help me weigh whether the potential benefit of an experimental drug at this stage is worth the unknowns compared to best supportive care or other available options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Phase 1: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 3 years
2
Phase 1: Percentage of Participants Experiencing Dose-Limiting Toxicities (DLTs)
. 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.
. Serum albumin \< 2.5 g/dL (patients should not receive IV albumin within 4 weeks prior to testing).
. Known active central nervous system metastases and/or carcinomatous meningitis. Note: Previously treated brain metastases allowed if follow-up brain imaging after CNS directed therapy shows no evidence of progression, and they have been off steroids for \> 4 weeks prior to first dose.
. Pregnant, lactating, or breastfeeding.
. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation.