Recruiting PHASE2 Metastatic Leiomyosarcoma

New treatment option for Metastatic Leiomyosarcoma

Official title XL092 (Zanzalintinib) for the Treatment of Patients With Metastatic or Unresectable Leiomyosarcoma, Bone Sarcoma or Translocation-associated Soft Tissue Sarcoma

ClinicalTrials.gov ID: NCT06571734

What this study is testing

What is Zanzalintinib?

Zanzalintinib is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic leiomyosarcoma.

Also referred to as Multi-kinase Inhibitor XL092, XL 092.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing: 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.

Phase 2: a mid-size study of how well it works
Time commitment: about 5 years

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

For Cohort 1 - Leiomyosarcoma:
Patients must have histologically confirmed leiomyosarcoma that has been clinically determined to be metastatic or unresectable. Pathology must have...
Patients must have undergone at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase...
Patients must have histologically confirmed diagnosis of metastatic or unresectable bone sarcoma. Pathology must have been reviewed at a National...
Patients must have undergone at least 1 line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor...

You likely can't join if

Patients who have received previous treatment with XL092.
Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study...
Patients who have received \> 2 prior tyrosine kinase inhibitor therapies as anticancer treatments.
Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to start of study treatment unless they have recovered from their...
Patients who have received radiation therapy for bone metastasis within 14 days prior to registration
Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment

See the full eligibility criteria

Who can join

For Cohort 1 - Leiomyosarcoma:
Patients must have histologically confirmed leiomyosarcoma that has been clinically determined to be metastatic or unresectable. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN)...
Patients must have undergone at least 2 or more lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI). For Cohort 2 - Bone Sarcoma:
Patients must have histologically confirmed diagnosis of metastatic or unresectable bone sarcoma. Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN) designated cancer center such as...
Patients must have undergone at least 1 line of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI). For Cohort 3 - Translocation-associated Soft Tissue Sarcoma:
Patients must have histologically confirmed diagnosis of metastatic or unresectable translocation-associated soft tissue sarcoma (TAS). Pathology must have been reviewed at a National Comprehensive Cancer Network (NCCN)...
Patients must have undergone greater than 2 lines of antineoplastic treatment, but no more than 2 lines of treatment can be a tyrosine kinase inhibitor (TKI). for All Cohorts/Sarcoma Types
Patients must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1.
Patients must be aged ≥ 18 years on day of signing any informed consent documents.
Patients must exhibit a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale or \> 70% on the Karnofsky Scale.
Absolute neutrophil count (ANC) ≥ 1,500/mcL (without granulocyte colony-stimulating factor support within 21 days of screening sample collection)
Hemoglobin (Hgb) ≥ 9 g/dL without transfusion within 21 days of screening laboratory sample collection
Platelets (PLT) ≥ 100,000/mm\^3 (\> 100 GI/L) without transfusion within 21 days of screening laboratory sample collection
International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (aPTT) ≤ 1.2 x upper limit of normal (ULN)
Total bilirubin ≤ 1.5 x institutional upper limit of normal ULN; for patients with Gilbert's disease, total bilirubin ≤ 3 x ULN
Alanine aminotransferase (AST) ≤ 3 x institutional ULN
Aspartate aminotransferase (ALT) ≤ 3 x institutional ULN
Alkaline phosphatase (ALP) ≤ 3 x institutional ULN; for patients with documented bone metastasis, ALP ≤ 5 x ULN
Serum creatinine ≤ 1.5 x institutional ULN OR calculated creatinine clearance ≥ 40 mL/min ( ≥ 0.67 mL/sec) using the Cockcroft-Gault equation
Creatinine clearance ≥ 40mL/min
Urine protein-to-creatinine ratio (UPCR) ≤ 1 mg/mg ( ≤ 113.12 mg/mmol)
Patient of child-bearing potential (POCBP) and any of their partners with sperm-producing reproductive capability must agree to use a highly effective method of contraception throughout the course of the study and for...
Patients with sperm-producing reproductive capacity (PWSPRC) treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence), with partners of...
Patients must have ejection fraction \> 50% by either MUGA scan or echocardiogram.
Patients must be capable of understanding and complying with the protocol requirements.
Patients must have the ability to understand and the willingness to sign a written informed consent document.

What rules you out

Patients who have received previous treatment with XL092.
Patients who have received any type of small-molecule kinase inhibitor (including an investigational kinase inhibitor) within 14 days prior to study day 1 treatment.
Patients who have received \> 2 prior tyrosine kinase inhibitor therapies as anticancer treatments.
Patients who have had prior chemotherapy, or radiation therapy within 4 weeks prior to start of study treatment unless they have recovered from their prior therapy (toxicity and/or complications) such that they now meet...
Patients who have received radiation therapy for bone metastasis within 14 days prior to registration
Patients who have undergone systemic treatment with radionuclides within 6 weeks (42 days) before first dose of study treatment
Patients with clinically relevant complications from prior radiation therapy requiring ongoing therapy, per the opinion of the treating investigator enrolling the patient.
Patients with a known prior or concurrent malignancy that is progressing or requires active treatment within 2 years of first dose of study treatment. Note: The following exceptions may be made:
For patients with malignancies like basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer; or superficial skin cancers...
For patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen.
Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study...
Patients who are on concomitant anticoagulation therapy with oral anticoagulants (e.g., warfarin or direct thrombin and factor Xa inhibitors) and platelet inhibitors (e.g., clopidogrel). Note: Allowed anticoagulants are...
Patients who are taking any complementary medications (e.g., herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks (14 days) prior to start of treatment. Note: taking...
The patient has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Cardiovascular disorders:
Congestive heart failure New York Heart Association class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias (e.g., ventricular flutter, ventricular fibrillation, Torsades de pointes)
Uncontrolled hypertension defined as sustained blood pressure (BP) \> 140 mm Hg systolic of \> 90 mm Hg diastolic despite optimal antihypertensive treatment
Stroke (including transient ischemic attack [TIA]), myocardial infarction, or other clinically significant ischemic events within 12 months prior to first dose of study treatment. Note: Patients who did not require...
Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-cerebrovascular accident (CVA)/TIA arterial thromboembolic events within 6 months before to first dose of study...
Prior history of myocarditis
Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation:
Tumors invading the GI tract from external viscera
Active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis
Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess must be confirmed prior to first dose of study treatment
Known gastric or esophageal varices
Acute obstruction of the bowel, gastric outlet, or pancreatic or biliary duct within 6 months unless cause of obstruction is definitively managed and subject is asymptomatic
Patients with clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 mL) of red blood, or other history of significant bleeding (e.g., pulmonary hemorrhage) within 84 days prior to...
Symptomatic cavitating pulmonary lesions or endobronchial disease (asymptomatic or radiated lesions allowed).
Lesions invading major blood vessel including but not limited to inferior vena cava, pulmonary artery, or aorta. Note: Patients with intravascular tumor extension (e.g., tumor thrombus in renal vein or inferior vena...
Patients who are capable of donating eggs for the purpose of reproduction must not do so throughout the course of the study and for 186 days after the last dose of treatment
Patients who are capable of donating sperm for the purpose of reproduction must not do so throughout the course of the study and for 96 days after the last dose of treatment
Other clinically significant disorders that would preclude safe study participation, including, but not limited to:
Active infection requiring systemic treatment. Note: This criterion applies only at enrollment; if a patient develops an infection while on study treatment, they may continue to receive study treatment. Note...
Known infection with acute or chronic hepatitis B or C, known human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS)-related illness
Known positive test for or suspected infection with SARS-CoV-2 within one month prior to enrollment. Note: Demonstration that the patient has fully recovered from the infection is required to be eligible for enrollment
Serious non-healing wound/ulcer/bone fracture. Note: non-healing wounds or ulcers are permitted if they are due to tumor-associated skin lesions
Malabsorption syndrome
Pharmacologically uncompensated, symptomatic hypothyroidism
Moderate to severe hepatic impairment (Child-Pugh B or C)
Requirement for hemodialysis or peritoneal dialysis
History of solid organ or allogenic stem cell transplant
Recent surgery within the following parameters:
Major surgery (e.g., GI surgery or removal/biopsy of brain metastasis) within 8 weeks prior to study treatment
Minor surgery (e.g., simple excision, tooth extraction) within 5 days prior to first dose of study treatment. Note: if a patient has had a recent surgery outside of the proscribed interval, complete wound healing from...
Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms within 14 days per electrocardiogram (ECG) prior to first dose of study treatment Note: Triplicate ECG evaluations will be performed and the...
Patients with any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) grade \> 1 at baseline from a previous anticancer therapy, with the following exceptions:
Alopecia, vitiligo, and the laboratory values
Patients with grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the treating physician
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with XL092 may be included only after consultation with the principal investigator
Patients who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to XL092
Patients who are pregnant (positive serum or urine test within 72 hours prior to enrollment) or nursing. Pregnant people are excluded from this study because XL092 is a next-generation tyrosine kinase inhibitor with...
Patients with psychiatric illness/social situations that would limit compliance with study requirements, per the opinion of the treating investigator
XL092 is administrated orally; patients who are unable to swallow, retain, and/or absorb pills are not eligible for this study
Patients who are currently participating in or have participated in a study of an investigational agent or have used an investigational device within 4 weeks prior to the first dose of treatment
Other conditions which, in the opinion of the Investigator, would compromise the safety of the patient or the patient's ability to complete the study

The study team makes the final eligibility decision.

Where it's taking place

Chicago, Illinois, United States

Compensation & support

A stipend or compensation may be offered.

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.