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Recruiting NCT06568562

XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer

Conditions: Metastatic Castration-resistant Prostate Cancer

Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 32
Sponsor: University of Utah

Location: Huntsman Cancer Institute at University of Utah Salt Lake City Utah

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Participant aged ≥ 18 years * Disease criteria: --Histologically or cytologically confirmed prostatic adenocarcinoma without small cell histology * Radiographic evidence of metatstatic disease * Progression on or after prior treatment with 177Lu-PSMA-617 as determined by clinical investigator * ECOG Performance Status ≤ 2. * Adequate organ function as defined as: * Absolute neutrophil count ≥ 1500/mm3 . * Platelet count ≥ 100,000/mm3 . * Hemoglobin ≥ 9 g/dL . * Total Bilirubin ≤ 1.5x institutional ULN. For subject's with Gilbert's disease, ≤ 3 x ULN. * Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤ 3 x ULN. For subjects with documented bone metastasis ALP ≤ 5 x ULN. For subjects with CRPC and bone metastasis ALP ≤ 10 x ULN if predominantly bone-specific ALP. * International Normalized Ratio (INR) ≤ 1.5 and activated partial thromboplastin time (aPTT) ≤ 1.2 upper limit of normal (ULN) * Serum creatinine ≤ 1.5 x ULN or estimated creatinine clearance ≥ 40 mL/min by Cockcroft-Gault formula: ---Males: ((140-age)×weight\[kg\])/(serum creatinine \[mg/dL\]×72) * Urine protein-to-creatinine ratio (UPCR) ≤ 1.5 mg/mg (≤ 169.8 mg/mmol) creatinine or 24-hour urine protein \ 140 mm Hg systolic or \> 90 mm Hg diastolic despite optimal antihypertensive treatment. * Stroke (including transient ischemic attack \[TIA\]), myocardial infarction, or other clinically significant ischemic event within 6 months before first dose of study treatment. * Pulmonary embolism (PE) or deep vein thrombosis (DVT) or prior clinically significant venous or non-CVA/TIA arterial thromboembolic events within 3 months before to first dose of study treatment. Note: Subjects with a diagnosis of DVT within 3 months are allowed if asymptomatic and stable at screening and treated with anticoagulation per standard of care before first dose of study treatment. Note: Subjects who don't require prior anticoagulation therapy may be eligible but must be discussed and approved by the Principal Investigator. --Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: * Tumors invading the GI-tract from external viscera, tumors invading respiratory tracts * Active peptic ulcer disease, inflammatory bowel disease including, ulcerative colitis or Crohn's disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, or acute pancreatitis * 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 * Abdominal fistula, gastrointestinal perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose. Note: Complete healing of an intra-abdominal abscess must be confirmed before first dose of study treatment. * Known gastric or esophageal varices * Abdominal/peritoneal carcinomatosis * Active perianal abscess * History of pelvic or abdominal perforation * History of bowel resection unless determined to be low risk of perforation by clinical investigator * History of radiation therapy to the abdomen unless determined to be low risk of perforation by clinical investigator * Prior GI surgery (particularly when associated with delayed or incomplete healing) unless completely healed and determined to be low risk of perforation by clinical investigator * Clinically significant hematuria, hematemesis, or hemoptysis of \> 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose of study treatment. * Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. * Lesions invading major blood vessel including, but not limited to, inferior vena cava, pulmonary artery, or aorta. Note: Subjects with intravascular tumor extension (eg, tumor thrombus in renal vein or inferior V. cava) may be eligible following Principal Investigator approval. * Other clinically significant disorders that would preclude safe study participation. * Active infection requiring systemic treatment. Note: Prophylactic antibiotic treatment is allowed. * 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 clinically significant SARS-CoV-2 within one month before enrollment. Note: demonstration that the subject has fully recovered from the infection as determined by clinical investigator is required to be eligible for enrollment * Serious non-healing wound/ulcer/bone fracture. Note: non-healing wounds or ulcers are permitted if 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 allogeneic stem cell transplant. * Major surgery (as defined in Appendix B; eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks prior to first dose of study treatment. Prior laparoscopic nephrectomy within 4 weeks prior to first dose of study treatment. Minor surgery (eg, simple excision, tooth extraction) within 10 days before first dose of study treatment. Complete wound healing from major or minor surgery must have occurred at least prior to first dose of study treatment. Note: Fresh tumor biopsies should be performed at least 7 days before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior surgical procedures, including biopsies, are not eligible. -Corrected QT interval calculated by the Fridericia formula (QTcF) \> 480 ms for males within 14 days per electrocardiogram (ECG) before first dose of study treatment. Note: Triplicate ECG evaluations will be performed and the average of these 3 consecutive results for QTcF will be used to determine eligibility. * History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent. * Inability to swallow tablets. * Previously identified allergy or hypersensitivity to components of the study treatment formulations. * Any other active malignancy or diagnosis of another malignancy within 2 years before first dose of study treatment requiring systemic treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator. * 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. * Participants taking prohibited medications as described in Section 6.8. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.

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Source: ClinicalTrials.gov (NCT06568562). StuddyBuddy aggregates publicly available trial information.