XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer
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
| Condition(s) | Metastatic Castration-resistant Prostate Cancer |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 18 Years |
| Sex | Male |
| Lead sponsor | University of Utah |
| Locations | Salt Lake City, Utah, United States |
| Start date | 2024-12-09 |
| NCT ID | NCT06568562 |
| Official listing | https://clinicaltrials.gov/study/NCT06568562 |