XL092 in Patients With Metastatic Castration-Resistant Prostate Cancer
NCT Number: NCT06568562
Acronym: PRO-XL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: DRUG: XL092
Sponsor: University of Utah
Collaborators: Exelixis
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2028-12
Locations: Huntsman Cancer Institute at University of Utah, Salt Lake City, Utah, 84112, United States

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.

Primary Outcome Measures: Proportion of participants with non-progressive disease after 16 weeks of treatment with XL092 as assessed by Prostate Cancer Working Group 3 (PCWG3)-modified RECIST v1.1, To evaluate the disease control rate at 16 weeks in metastatic castrate-resistant prostate cancer (mCRPC) patients treated with XL092 after progression on 177Lu-PSMA-617, 16 weeks
Secondary Outcome Measures: Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type., To evaluate the safety and tolerability of XL092 in the study population., 5 years|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 5.0)., To evaluate the safety and tolerability of XL092 in the study population., 5 years|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness., To evaluate the safety and tolerability of XL092 in the study population., 5 years|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration., To evaluate the safety and tolerability of XL092 in the study population., 5 years|Frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by relationship to study treatment., To evaluate the safety and tolerability of XL092 in the study population., 5 years|rPFS as defined as the time from study drug initiation to the time of documented disease progression (as assessed by PCWG3 modified RECIST 1.1) or death from any cause., To evaluate radiographic progression-free survival (rPFS) in the study population., 5 years|PFS as defined as the time from study drug initiation to the time documented clinical or radiological disease progression (as assessed by PCWG3 modified RECIST 1.1) or death from any cause., To evaluate progression-free survival (PFS) in the study population., 5 years.|PSA PFS as defined as the time from study drug initiation to the time of documented PSA progression per PCWG3 criteria., To evaluate PSA progression-free survival (PSA PFS) in the study population., 5 years|The proportion of patients achieving PSA decline of ≥ 50% compared to the baseline value prior to starting study treatment., To evaluate the PSA 50% response rate in the study population., 5 years|Overall survival (OS) as defined as the time from study drug initiation until death from any cause., To evaluate overall survival in this study population, 5 years