Study of SX-682 Plus Enzalutamide in Men With ARPI-Resistant Metastatic Castration Resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorSyntrix Biosystems, Inc.
About this trial
The goal of this clinical trial is to study the combination of SX-682 plus enzalutamide in men with metastatic castration resistant prostate cancer (mCRPC) who have failed prior therapy with androgen receptor pathway inhibitors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed and dated Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form prior to beginning study and undergoing procedures.
rising PSA (a rising PSA requires at least 3 measurements obtained at least 1 week apart showing increase from nadir with the last level above 2 ng/mL by local testing); or
progression of new or existing bone or soft tissue metastatic lesions by CT, MRI or bone scan; no washout necessary.
Availability of archival tumor tissue for pathologic review and correlative studies. Tumor tissue (localized or metastatic) does not need to be received but rather identified and available (slides and blocks) upon later request for future pathologic review and possible correlative studies.
Disqualifiers
Prior treatment with docetaxel or marketed antibody within 4 weeks of first dose of study treatment
Prior radium-223 therapy within 6 weeks
Prior PSMA-Lu177-617 therapy within 4 weeks
2. Prior receipt of (a) ketoconazole, (b) 2 or more chemotherapy regimens with docetaxel or (c) any chemotherapy other than docetaxel.
Trial design
Design model
Single group
Treatments tested in this trial
SX-682
DrugSpecified dose twice daily
Enzalutamide
DrugSpecified dose once daily
Treatment groups
53 Participants
are divided into 1 treatment groupGroup A: SX-682 + enzalutamideExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Clinical Benefit
A composite endpoint defined as 1) iRECIST iCR or iPR, 2) PSA50 or 3) stable disease by iRECIST and PCWG3 bone scan criteria for at least 6 months
Time frame
Ten 21-day treatment cyclesSecondary outcomes
1
Adverse Events
Number of participants experiencing adverse events (AEs)
Time frame
Ten 21-day treatment cycles2
Progression-free survival
Time from the date study treatment starts to the earliest progression event
Time frame
Ten 21-day treatment cycles3
Overall survival
The time from the start of study treatment until death due to any cause
Time frame
Up to 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Syntrix Biosystems, Inc.
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov