Actively Recruiting

Phase 2
Age: 18Years +
MALE
NCT06568562

XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer

Led by University of Utah · Updated on 2025-12-09

32

Participants Needed

1

Research Sites

207 weeks

Total Duration

On this page

Sponsors

U

University of Utah

Lead Sponsor

E

Exelixis

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to determine how well the study drug XL092 is helping to treat a participant's cancer after 16 weeks of treatment. Researchers will also look at how safe the XL092 is and how well the XL092 is working. XL092 is an oral tablet that will be taken once a day. Participants will return to clinic for regular visits for checkups and tests.

CONDITIONS

Official Title

XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant aged 63 18 years
  • Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology
  • Radiographic evidence of metastatic disease
  • Progression on or after prior treatment with 177Lu-PSMA-617 as determined by clinical investigator
  • ECOG Performance Status 64 2
  • Adequate organ function including: -- Absolute neutrophil count 63 1500/mm3 -- Platelet count 63 100,000/mm3 -- Hemoglobin 63 9 g/dL -- Total Bilirubin 64 1.5x institutional ULN (up to 3x ULN for Gilbert's disease) -- ALT, AST, ALP 64 3x ULN (up to 5x or 10x ULN for bone metastasis as specified) -- INR 64 1.5 and aPTT 64 1.2 ULN -- Serum creatinine 64 1.5x ULN or creatinine clearance 65 40 mL/min -- Urine protein-to-creatinine ratio 64 1.5 mg/mg or 24-hour urine protein <1.5 g
  • Sexually active fertile subjects and partners must agree to use highly effective contraception plus an additional method during and for 96 days after treatment
  • Recovery from prior oncologic treatment side effects (CTCAE grade 5B1 acceptable; grade 5B2 may be acceptable per investigator)
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Prior treatment with XL092
  • Receipt of small molecule kinase inhibitor, cytotoxic, biologic, or other systemic anticancer therapy within 2 weeks or at least 5 half-lives before starting study treatment
  • Radiation therapy within 2 weeks before starting study treatment or ongoing complications from prior radiation
  • Known brain metastases or cranial epidural disease unless treated and stable for at least 4 weeks
  • Use of certain anticoagulants unless specified exceptions apply
  • Use of complementary medications for the disease within 2 weeks or at least 5 half-lives before treatment
  • Uncontrolled or significant recent illnesses including: -- Severe cardiovascular disorders (e.g., CHF class 3/4, unstable angina, serious arrhythmias) -- Uncontrolled hypertension -- Recent stroke, myocardial infarction, or ischemic events within 6 months -- Recent pulmonary embolism or deep vein thrombosis within 3 months unless stable
  • High-risk gastrointestinal disorders or recent GI tract complications
  • Significant bleeding events within 12 weeks
  • Cavitating pulmonary lesions or lesions invading major blood vessels
  • Other serious disorders preventing safe participation
  • Active infections requiring systemic treatment or significant viral infections
  • Serious non-healing wounds or ulcers unless tumor-associated
  • Malabsorption syndrome
  • Uncompensated hypothyroidism
  • Moderate to severe hepatic impairment
  • Requirement for dialysis
  • History of organ or stem cell transplant
  • Major surgery within 8 weeks or minor surgery within 10 days before treatment
  • QTcF > 480 ms on ECG within 14 days before treatment
  • Psychiatric illness interfering with study compliance
  • Inability to swallow tablets
  • Allergy or hypersensitivity to study treatment components
  • Other active malignancies requiring systemic treatment within 2 years except certain cured or localized tumors
  • Use of prohibited medications without appropriate washout period prior to treatment start
  • Other conditions deemed unsafe by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

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Research Team

S

Susan Sharry

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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