Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma (NCT06957431) | Clinical Trial Compass
RecruitingPhase 1
Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
United States18 participantsStarted 2025-10-22
Plain-language summary
The investigators hypothesize that the combination of eribulin and zanzalintinib will be tolerable and lead to improved progression-free survival (PFS) as compared to eribulin alone based on historical data.
Who can participate
Age range
18 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:
* Pathologically proven diagnosis of unresectable or metastatic leiomyosarcoma or adipocytic sarcoma.
* Progressed on at least 1 line of prior therapy and have received no more than 4 lines of prior therapy.
* Measurable disease per RECIST 1.1.
* At least 18 years of age.
* ECOG performance status ≤ 1
* Adequate bone marrow and organ function within 14 days before first dose of study treatment as defined below:
* Absolute neutrophil count ≥ 1.5 K/cumm without granulocyte colony-stimulating factor support within 2 weeks of collection
* Platelets ≥ 100 K/cumm without transfusion within 2 weeks of collection
* Hemoglobin ≥ 9.0 g/dL without transfusion within 2 weeks of collection
* INR ≤ 1.5 x ULN and aPTT ≤ 1.2 x ULN; for subjects on Factor Xa inhibitors, this criterion does not apply.
* Total bilirubin ≤ 1.5 x IULN (for subjects with Gilbert's disease, ≤ 3.0 x IULN)
* AST(SGOT)/ALT(SGPT)/alkaline phosphatase (ALP) ≤ 3.0 x IULN (for subjects with documented bone metastasis, ALP ≤ 5.0 x IULN)
* Serum albumin ≥ 2.8 g/dL
* Serum creatine ≤ 1.5 x IULN or calculated creatinine clearance ≥ 40 mL/min by Cockcroft-Gault
* UPCR ≤ 1 mg/mg (≤ 113.2 mg/mmol) creatinine
* Recovery to baseline or ≤ grade 1 from AEs, including immune-related AEs related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy (e.g., physiological replacement of corticosteroid). Low-grade or controlled toxicities such as alope…
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.
What they're measuring
1
Number of adverse events experienced by participants
Timeframe: From start of treatment through 30 days after completion of treatment (estimated to be 25 months)
2
Maximum tolerated dose (MTD)/recommended phase II dose (RP2D)
Timeframe: Through cycle 1 of treatment (each cycle is 21 days)