NCT06957431 Zanzalintinib Combined With Eribulin in Advanced Liposarcoma and Leiomyosarcoma
| NCT ID | NCT06957431 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Washington University School of Medicine |
| Condition | Advanced Leiomyosarcoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2025-10-22 |
| Primary Completion | 2028-11-30 |
Trial Parameters
Eligibility Fast-Check
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Brief 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.
Eligibility Criteria
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 metas