New pill aims to stall advanced prostate cancer when hormone drugs fail
NCT ID NCT06636123
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests an oral drug called GZ17-6.02 in 30 men with castration-resistant prostate cancer that has progressed after standard hormone therapy. The goal is to see if the drug can delay cancer growth for at least 6 months. Participants take the drug twice daily with a high-fat meal until the cancer worsens or side effects become too severe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GZ17-6.02
- What this could lead to
- If it works, this could offer a new oral option to delay cancer progression in men with advanced prostate cancer who have stopped responding to standard hormone therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 30 participants, so it is too soon to know if GZ17-6.02 is effective or safe. Many early-stage drugs do not succeed in larger studies.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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. * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
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Other studies related to the condition(s) this trial covers.
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