NCT06571734

XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma

A Single-Arm, Open-label Phase II Trial Testing the Activity of XL092 (Zanzalintinib) in Patients With Advanced Leiomyosarcoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial tests how well zanzalintinib (XL092) works in treating patients with leiomyosarcoma that has spread from where it first started to other places in the body (metastatic) or that cannot be removed by surgery (unresectable). Leiomyosarcomas are a type sarcoma that can occur in any location in the body, such as the uterus or in the abdomen. Current standard treatment for leiomyosarcoma only shows a progression-free survival of 4-6 months. XL092, a tyrosine kinase inhibitor, interferes with cell communication and growth and may prevent tumor growth. Giving XL092 may kill more tumor cells in patients with metastatic or unresectable leiomyosarcoma.

Detailed description

PRIMARY OBJECTIVE: I. Evaluate 6-month progression-free survival (PFS) of patients with advanced leiomyosarcoma (LMS) who have been treated with zanzalintinib (XL092) monotherapy. SECONDARY OBJECTIVES: I. Evaluate median progression-free survival (PFS) in patients with advanced LMS who have been treated with XL092 monotherapy. II. Determine overall survival (OS) in patients with advanced LMS who have been treated with XL092 monotherapy. III. Determine overall response rate (ORR) in patients with advanced LMS who have been treated with XL092 monotherapy. IV. Assess duration of response (DOR) in patients with advanced LMS who have been treated with XL092 monotherapy. V. Assess toxicity of XL092 in patients with advanced LMS who have been treated with such as monotherapy. OUTLINE: Patients receive XL092 orally (PO) once daily (QD) on days 1-14 of each cycle. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients also undergo echocardiography (ECHO) or multigated acquisition scan (MUGA) at screening and then as clinically indicated, and blood sample collection on study and computed tomography (CT) throughout the study. After completion of study treatment, patients are followed up at 30 days, then every 12 weeks for 2 years followed by every 6 months for up to 5 years from start of study treatment.

Conditions

• Metastatic Leiomyosarcoma
• Unresectable Leiomyosarcoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT
PROCEDURE	Echocardiography	Undergo ECHO
PROCEDURE	Multigated Acquisition Scan	Undergo MUGA
DRUG	Zanzalintinib	Given PO

Timeline

• Start date: 2024-09-19
• Primary completion: 2028-07-01
• Completion: 2029-07-01
• First posted: 2024-08-26
• Last updated: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study