PRO-XL: A Phase II Study of XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer After Progression on Lutetium-177 (177Lu)-PSMA-617
University of 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
- Age range
- 18+ years
- Sex
- Male
- Healthy volunteers
- No
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. *…
Interventions
- DrugXL092
XL092 will be supplied as a tablet that will be taken at home once a day. Participants should drink at least 8 ounces of water with each dose of XL092. Participants should not eat at least 2 hours before taking the dose and 1 hour after. Participants will be given enough XL092 to take at home for a full cycle.
Location
- Huntsman Cancer Institute at University of UtahSalt Lake City, Utah