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Castration-resistant Prostate CancerPhase 1NCT06636123

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

A Phase 1 study testing Investigational Agent Administration in people with Castration-resistant Prostate Cancer, run by Virginia Commonwealth University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Castration-resistant Prostate Cancer
What is being tested?
Investigational Agent Administration
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
18 Feb 2025to 31 Oct 2031
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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
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  • 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

Who cannot join

  • 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.
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  • 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.
  • Inability to swallow medication.
  • Known hypersensitivity to GZ17-6.02 components (curcumin, harmine, and isovanillin) or excipients.
  • Known or suspected malabsorption condition or obstruction.
  • Active untreated hepatitis B or C" and "Known liver cirrhosis of any cause, active nonalcoholic steatohepatitis, or nonalcoholic fatty liver disease. Note: no additional testing necessary to confirm
  • Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Massey IIT Research Operations contact

804-628-6430

masseyepd@vcu.edu

United States1 site, 1 recruiting

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

    Massey CTO GU Team, 804-628-6430, masseygu@vcu.edu

    John Melson, MD

    Recruiting

Other trials in United States

About this study

Official title: GZ17-6.02 in Advanced Castration-Resistant Prostate Cancer (CRPC) After Progression on Anti-Androgen Therapy

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

Read the detailed description

This single-arm phase Ib study will assess whether GZ17-6.02, a combination of curcumin, harmine, and isovanillin, delays radiographic progression of castration-resistant prostate cancer among men previously treated with androgen deprivation therapy and an androgen receptor pathway inhibitor. All participants in the study will receive GZ17-6.02. The study will also assess the safety and tolerability of GZ17-6.02 and explore patient-reported outcomes.

Being tested
Investigational Agent Administration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Investigational Agent AdministrationDrug

    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

Study groups in NCT06636123
Study groupRoleWhat they receive
Investigational Agent AdministrationExperimentalGZ17-6.02: 375mg twice daily
Receives: Drug: Investigational Agent Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Number of participants with rPFS for 6 months or longer

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

Secondary outcomes (6)

  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).

    Measured: Up to 5 years following end of study treatment

  2. Measure the duration of response of CRPC tumors to GZ17-6.02

    Duration of tumor response, measured by time to increase in PSA.

    Measured: Up to 5 years following end of study treatment

  3. 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.

    Measured: Up to 5 years following end of study treatment

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

    Duration of radiographic response

    Measured: Up to 5 years following end of study treatment

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

    Overall patient survival, defined as date of diagnosis to date of death

    Measured: Up to 5 years following end of study treatment

  6. Determine the safety and tolerability of twice daily treatment with GZ17-6.02

    Incidence of adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Beginning of study treatment through the 30-day follow-up safety assessment up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2024
  2. Study start18 Feb 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion31 Oct 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06636123
Sponsor's protocol ID
MCC-23-20417
Other IDs
HM20030070
Status last verified
Jan 2026
First submitted
8 Oct 2024
Last updated
27 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Currently, there are no plans to share IPD.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Investigational Agent Administration in people with Castration-resistant Prostate Cancer, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Massey IIT Research Operations (804-628-6430, masseyepd@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiologic progression-free survival (rPFS) for 6 months or longer (time frame: 6 months and up to 5 years after end of study treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06636123.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.

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