Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT06636123

GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy

Led by Virginia Commonwealth University · Updated on 2026-01-27

30

Participants Needed

1

Research Sites

349 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this clinical trial is to determine if GZ17-6.02 delays progression of castration-resistant prostate cancer.

CONDITIONS

Official Title

GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with prostate cancer and treated with androgen deprivation therapy and at least one androgen receptor pathway inhibitor
  • Androgen levels 50 ng/dL (1.73 nmol/L) or lower
  • Disease progression after androgen deprivation therapy and androgen receptor pathway inhibitor treatment
  • PSA progression shown by rising PSA in 2 assessments at least 7 days apart
  • Measurable disease by RECIST v1.1 on chest/abdomen/pelvis CT or evaluable disease on bone scan
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Liver function with total bilirubin ≤1.5 times upper limit of normal, ALT and AST ≤3 times upper limit of normal at screening
  • Kidney function with creatinine clearance ≥30 mL/min
  • Absolute neutrophil count ≥1,500 cells/mm3
  • Platelets ≥100,000 cells/mm3
  • Serum hemoglobin level ≥8 g/dL
  • Agree not to donate blood or sperm during the study and for 90 days after last dose
  • Use highly effective contraception if having sexual partners of childbearing potential
  • Ability and willingness to sign informed consent
Not Eligible

You will not qualify if you...

  • Use of any investigational agent within 4 weeks or less than 5 half-lives before starting study treatment
  • Low PSA (≤10 ng/mL) at initial presentation plus high volume (≥20) bone metastases
  • Participation in another cancer treatment clinical trial simultaneously
  • Active uncontrolled diarrhea causing dehydration or electrolyte problems not controlled with oral treatment
  • Grade 3 or higher uncontrolled infection
  • Major surgery within 3 weeks before starting study treatment
  • Not fully recovered from surgery-related side effects to grade 1 or lower within 3 weeks before treatment
  • Small cell, anaplastic, or neuroendocrine tumor component
  • Known active brain metastasis
  • Known active leptomeningeal disease
  • Planned ongoing use of drugs that may interact negatively with study medications unless stopped 2 weeks before treatment, including MAO inhibitors, strong/moderate CYP1A2, CYP3A4, CYP2C19 inhibitors, and certain PARP inhibitors
  • Inability to swallow medication
  • Known allergy to components of GZ17-6.02 or its excipients
  • Known or suspected malabsorption or intestinal obstruction
  • Active untreated hepatitis B or C or known liver cirrhosis, active nonalcoholic steatohepatitis, or fatty liver disease
  • Medical, psychological, or social conditions that may increase risk or limit adherence to study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

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Research Team

M

Massey IIT Research Operations

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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