ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma (NCT05116683) | Clinical Trial Compass
TerminatedPhase 2
ATX-101 in Advanced Dedifferentiated Liposarcoma and Leiomyosarcoma
Stopped: Study terminated by PI
United States4 participantsStarted 2022-01-11
Plain-language summary
The purpose of this study is to evaluate the effectiveness of a new investigational drug, ATX-101, for the treatment of dedifferentiated liposarcoma (LPS) and leiomyosarcoma (LMS). ATX-101 is an intravenous (IV) drug which blocks the interaction of a protein called PCNA with a number of "stress response" proteins. These interactions are thought to be important for cancer cell survival and growth. ATX-101 may disrupt these interactions and therefore help treat the cancer. In this study, all patients will receive the same treatment. Most of the exams, tests, and procedures are part of the usual approach to medical care for this condition. However, some additional tests or procedures may be performed, and other tests may be performed more frequently than usual.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
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 dedifferentiated liposarcoma (LPS) or leiomyosarcoma
* ATX-101 in Sarcoma Phase II
* (LMS). Pathology review occurs at the center enrolling the patient on this trial.
* Disease must be locally advanced and unresectable or metastatic. Disease which may be resected but with an associated level of morbidity deemed unacceptable by the treating clinician is considered eligible.
* Patients must have measurable disease by RECIST criteria version 1.1. In addition, the first 10 patients enrolled on the study must have a site of disease amenable to image-guided biopsy at minimal risk or less, and must agree to undergo this biopsy.
* Patients must evidence of disease progression, either clinically or radiographically, within the 12 weeks prior to study enrollment, as determined by the investigator enrolling the patient on the study.
* Patients must have been treated with at least one prior systemic regimen for advanced sarcoma: LMS: Anthracycline-based chemotherapy, or gemcitabine/docetaxel. LPS: No specification as to the prior treatment received. Neoadjuvant or adjuvant systemic therapy does not qualify as prior treatment unless completed within 6 months of disease relapse.
* Patients must be age 18 years or older. Because the safety of ATX-101 in patients less than 18 years of age has not been characterized, children are excluded from the present study.
* Patients must demonstrate an Eastern Cooperative Oncology Group (ECOG) performance…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.