Actively Recruiting
XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma
Led by Northwestern University · Updated on 2026-01-09
29
Participants Needed
1
Research Sites
249 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed metastatic or unresectable leiomyosarcoma reviewed at a specialized cancer center
- Received one prior line of antineoplastic treatment, with no more than two lines involving tyrosine kinase inhibitors
- Measurable disease according to RECIST version 1.1
- Age 18 years or older at time of consent
- Performance status of 0 or 1 on ECOG scale or over 70% on Karnofsky scale
- Leukocytes (WBC) count at least 3,000/mcL
- Absolute neutrophil count (ANC) at least 1,500/mcL without recent growth factor support
- Hemoglobin at least 9 g/dL without recent transfusion
- Platelets at least 100,000/mm^3 without recent transfusion
- INR less than or equal to 1.5 and aPTT less than or equal to 1.2 times the upper limit of normal
- Total bilirubin less than or equal to 1.5 times institutional upper limit (or 3 times if Gilbert's disease)
- AST and ALT less than or equal to 3 times institutional upper limit
- Alkaline phosphatase less than or equal to 3 times institutional upper limit (or 5 times if bone metastasis present)
- Serum creatinine less than or equal to 1.5 times institutional upper limit or creatinine clearance at least 40 mL/min
- Urine protein-to-creatinine ratio less than or equal to 1 mg/mg
- Patients and partners with reproductive potential agree to use effective contraception during and after study as specified
- Ejection fraction greater than 50% by MUGA scan or echocardiogram
- Ability to understand and comply with study requirements and provide informed consent
You will not qualify if you...
- Prior treatment with XL092
- Use of small-molecule kinase inhibitors within 14 days before study start
- More than two prior tyrosine kinase inhibitor therapies
- Chemotherapy or radiation therapy within 4 weeks before study unless recovered
- Radiation therapy for bone metastasis within 14 days before registration
- Systemic radionuclide treatment within 6 weeks before study
- Active complications from prior radiation needing ongoing therapy
- Progressing or actively treated malignancy within 2 years except certain localized or low-grade cancers
- Known brain metastases or cranial epidural disease unless treated and stable for 4 weeks
- Use of oral anticoagulants and platelet inhibitors except allowed agents
- Use of complementary medications for cancer treatment within 14 days before registration
- Uncontrolled or significant illness including serious cardiovascular, gastrointestinal, bleeding, or infection conditions
- Recent major surgery within 8 weeks or minor surgery within 10 days before study
- QTcF interval greater than 480 ms on ECG prior to study
- Unresolved toxicity from prior cancer therapy grade 1 or higher except specified exceptions
- Allergic reactions to compounds similar to XL092
- Pregnant or nursing individuals
- Psychiatric or social conditions limiting compliance
- Inability to swallow or absorb oral medication
- Participation in another investigational study within 4 weeks prior
- Other conditions compromising patient safety or study completion per investigator judgment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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