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

NCT06636123 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MCC-23-20417HM20030070
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Radiologic progression-free survival (rPFS) for 6 months or longer

  Number of participants with rPFS for 6 months or longer

  6 months and up to 5 years after end of study treatment

Secondary Outcomes (6)

• Measure the biochemical response rate of CRPC tumors to GZ17-6.02

  Up to 5 years following end of study treatment

• Measure the duration of response of CRPC tumors to GZ17-6.02

  Up to 5 years following end of study treatment

• Assess the objective response rate (ORR) in CRPC patients treated with twice daily GZ17-6.02.

  Up to 5 years following end of study treatment

• Measure the duration of radiographic response in CRPC patients treated with twice daily GZ17-6.02

  Up to 5 years following end of study treatment

• Measure overall survival (OS) in CRPC patients treated with twice daily GZ17-6.02

  Up to 5 years following end of study treatment

Study Arms (1)

Investigational Agent Administration

EXPERIMENTAL

GZ17-6.02: 375mg twice daily

Drug: Investigational Agent Administration

Interventions

Investigational Agent Administration DRUG

GZ17-6.02 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

Investigational Agent Administration

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Measurable disease by RECIST v1.1 on chest/abdomen/pelvis CT or evaluable disease observed on bone scan.
• Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
• Appropriate hepatic function defined by a total bilirubin (TBL) ≤1.5 × the upper limit of normal (ULN), alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) ≤3 × ULN at screening.
• Appropriate kidney function defined by calculated or actual creatinine clearance ≥30 mL/min
• Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3.
• Platelets ≥100,000 cells/mm3.
• Serum hemoglobin level ≥8 g/dL.
• Agree to not donate blood or sperm during the study and for 90 days after the last dose of study treatment.
• Patients with sexual partners of childbearing potential must agree to use highly effective methods of contraception throughout the study
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Any investigational agent:
• within 4 weeks OR within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before initiating study treatment.
• 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.
• Major surgery (in the opinion of the treating investigator) ≤3 weeks before initiating study treatment.
• Not having fully recovered to a grade of 1 or lower from any surgery-related adverse effects within the 3 weeks preceding the start of the study treatment.
• Small cell, anaplastic, or neuroendocrine component.
• Known active brain metastasis.
• Known active leptomeningeal disease.
• Planned ongoing treatment with other drugs thought to potentially have adverse interactions with either of the medications included in the study treatment must be discontinued ≥2 weeks prior to initiating study treatment unless otherwise noted:
• Monoamine oxidase inhibitors (MAOI) use; must discontinue use 10 days prior to initiating study therapy.
• Strong or moderate CYP1A2, CYP3A4 and CYP2C19 inhibitors.
• Rucaparib, Olaparib and Talazoparib, due to their common findings of liver enzyme elevation.

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

Study Officials

• John Melson, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey IIT Research Operations

CONTACT

804-628-6430; masseyepd@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: February 18, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2031
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)