GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
ConditionCastration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorVirginia Commonwealth University
About this trial
The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with prostate cancer and treated with androgen deprivation therapy (ADT) and at least one androgen receptor pathway inhibitor (ARPI) (eg, abiraterone, enzalutamide, apalutamide or darolutamide). Previous prostate-specific membrane antigen (PSMA)-targeted therapy or cytotoxic chemotherapy is allowed but not required.
Androgen levels ≤50 ng/dL (≤1.73 nmol/L).
Disease progression following ADT and ARPI treatment described
PSA progression over 2 assessments, defined as rising PSA values from 2 consecutive assessments with an interval of at least 7 days between assessments. PSA levels prior to study enrollment are considered and appropriate for inclusion.
Disqualifiers
Low PSA (≤10 ng/mL) at initial presentation (before ADT or at symptomatic progression in the castrate setting) plus high volume (≥20) bone metastases.
Simultaneous enrollment in any other cancer treatment interventional clinical trial.
Active, uncontrolled diarrhea leading to dehydration or electrolyte disturbances not controlled with oral repletion.
Grade ≥3 uncontrolled infection.
Trial design
Design model
Single group
Treatments tested in this trial
Investigational Agent Administration
DrugGZ17-6.02 will be taken orally with a high-fat meal at a fixed dose of 375 mg twice daily each day of a 28-day cycle, continuing until progression or intolerable toxicity
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Investigational Agent AdministrationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Radiologic progression-free survival (rPFS) for 6 months or longer
Number of participants with rPFS for 6 months or longer
Time frame
6 months and up to 5 years after end of study treatmentSecondary outcomes
1
Measure the biochemical response rate of CRPC tumors to GZ17-6.02
Biochemical response measured by percentage of patients with any reduction in PSA, reduction in PSA by at least 30% (PSA30), and reduction in PSA by at least 50% (PSA50).
Time frame
Up to 5 years following end of study treatment2
Measure the duration of response of CRPC tumors to GZ17-6.02
Duration of tumor response, measured by time to increase in PSA.
Time frame
Up to 5 years following end of study treatment3
Assess the objective response rate (ORR) in CRPC patients treated with twice daily GZ17-6.02.
Best objective response (complete response, partial response, or stable disease ≥4 months) in patients with measurable disease by RECIST 1.1.
Time frame
Up to 5 years following end of study treatment4
Measure the duration of radiographic response in CRPC patients treated with twice daily GZ17-6.02
Duration of radiographic response
Time frame
Up to 5 years following end of study treatmentSponsors and contacts
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Source ClinicalTrials.gov