PRO-XL: A Phase II Study of XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer After Progression on Lutetium-177 (177Lu)-PSMA-617
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.
• 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 \<1.5 g.
• Sexually active fertile subjects and their partners must agree to use highly effective method of contraception (defined in Section 5.4.1) during the course of the study and for 96 days after the last dose of treatment (whichever is later). An additional contraceptive method, such as a barrier method (eg, condom), is required. In addition, men must agree not to donate sperm for the purpose of reproduction during these same periods.
• Must have recovered from adverse effects of any prior oncologic treatment (e.g. prior surgery, radiotherapy, or other antineoplastic therapy). CTCAE adverse events less than or equal to grade 1 are acceptable. CTCAE adverse events grade 2 or greater may be acceptable as determined by the Clinical Investigator.
• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.