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 range18 Years
SexALL
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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…
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)