ClinicalTrials.gg
Not yet recruitingNCT07914855Updated Nov 4, 2026

Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer

A Phase 2 interventional study of Antiandrogen Therapy and Biopsy Procedure in Metastatic Castration-Resistant Prostate Adenocarcinoma and Stage IVB Prostate Cancer AJCC v8, sponsored by National Cancer Institute (NCI). Not yet recruiting. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Study summary

This phase II trial tests how well enzomenib works in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow or spread despite androgen deprivation therapy (castration-resistant). The growth and survival of prostate tumor cells often depends on testosterone. Androgen deprivation therapy blocks the use of testosterone by the tumor cells. Although most tumors respond to androgen deprivation therapy at first, nearly all eventually progress to a castration-resistant state. Enzomenib, a menin inhibitor, targets and blocks menin, a protein that plays a role in the survival and growth of tumor cells.

Read the detailed description

PRIMARY OBJECTIVE:

I. To assess the efficacy of DSP-5336 (enzomenib) as measured by fluorodeoxyglucose (FDG)-positron emission tomography (PET) metabolic response rate, in patients with advanced treatment-refractory prostate cancer.

SECONDARY OBJECTIVES:

I. To determine the safety and tolerability of DSP-5336 (enzomenib) in patients with advanced treatment-refractory prostate cancer.

II. To determine the activity of DSP-5336 (enzomenib) in patients with advanced treatment-refractory prostate cancer.

III To assess the pharmacodynamics of DSP-5336 (enzomenib) in patients with advanced treatment-refractory prostate cancer.

IV. To assess the pharmacokinetics of DSP-5336 (enzomenib) in patients with advanced treatment-refractory prostate cancer.

EXPLORATORY OBJECTIVES:

I. To identify molecular subpopulations associated with response. II. To evaluate circulating tumor deoxyribonucleic acid (DNA) (ctDNA) as a predictor for response.

III. To evaluate differential metabolic responses between prostate-specific membrane antigen (PSMA)-positive and PSMA-negative lesions.

OUTLINE:

Patients continue to receive usual androgen deprivation therapy per standard of care. Patients receive enzomenib orally (PO) twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, FDG PET/computed tomography (CT), PSMA PET/CT, CT, bone scan and tissue biopsy throughout the study.

After completion of study treatment, patients are followed up at 30 days then every 3 months for up to 12 months.

02

Conditions studied

  • Metastatic Castration-Resistant Prostate Adenocarcinoma
  • Stage IVB Prostate Cancer AJCC v8

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03

In context

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

This study's planned enrollment of 24 is below the median of 60 across 5,348 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,556 studies on the registry; 336 are open to participants now.

Of its 411 completed or terminated interventional studies of FDA-regulated products, 373 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • At the time of , be ≥ 18 years of age. Because no dosing or adverse event data are currently available on the use of DSP-5336 (enzomenib) in patients \< 18 years of age, and because prostate cancer is an adult , pediatric patients are not part of the target disease population, therefore children are excluded from this study
  • confirmed prostate adenocarcinoma
  • disease documented by conventional imaging, including cross-sectional imaging (CT or magnetic resonance imaging [MRI]) and bone scan. Advanced imaging, including PSMA PET/CT or FDG PET/CT, may be used as supportive documentation but is not sufficient as the sole evidence of metastatic disease for eligibility
  • Patients with treated, stable are eligible if neurologically stable for ≥ 4 weeks and not requiring for central nervous system (CNS) disease for at least 7 days prior to registration. Routine screening for asymptomatic CNS metastases is not required
  • Participants with documented progressive metastatic castration-resistant prostate cancer (mCRPC), as assessed by the treating physician based on at least 1 of the following criteria:

    • Prostate specific antigen (PSA) progression may be used for study eligibility, either alone or with radiographic progression. PSA progression is defined as a rise in PSA that is both ≥ 25% and ≥ 2.0 ng/mL above the lowest PSA value since the start of the most recent systemic therapy, or above the pre-treatment baseline PSA if there was no PSA decline. The rise must be confirmed by a second PSA value obtained at least 3 weeks/21 days later. The reference PSA must be ≥ 1.0 ng/mL. Radiographic disease progression in soft tissue based on (RECIST) 1.1 criteria
    • Radiographic disease progression in bone, defined as appearance of 2 or more new bone lesions on bone scan
  • Participants must have received prior systemic therapy for advanced or metastatic prostate cancer, including both of the following:

    • At least one androgen receptor pathway inhibitor, such as abiraterone, enzalutamide, apalutamide, or darolutamide. Androgen receptor pathway inhibitor (ARPI) exposure in the metastatic castration-sensitive, non-metastatic castration-resistant, or metastatic castration-resistant setting may satisfy this requirement and
    • At least one prior taxane chemotherapy regimen, such as docetaxel or cabazitaxel, and/or PSMA-targeted radioligand therapy. At least one therapy satisfying this second requirement must have been administered in the metastatic castration-resistant setting
  • Prior poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor therapy, immunotherapy, radium-223, or other standard therapies are permitted but are not required to satisfy eligibility
  • Therapy administered solely in the localized, , adjuvant, or locally advanced setting does not count toward the required prior therapy history. Docetaxel administered solely in the metastatic castration-sensitive setting does not satisfy the required mCRPC therapy criterion
  • Prior orchiectomy or medical castration, with castrate levels of serum testosterone defined as testosterone ≤ 50 ng/dL documented prior to initiation of study treatment. Participants receiving medical castration with a gonadotrophin releasing hormone (GnRH) agonist or antagonist must continue androgen deprivation therapy throughout the treatment phase
  • (ECOG) performance status ≤ 2 ( ≥ 60%)
  • ≥ 1,000/mcL
  • ≥ 75,000/mcL
  • Total ≤ 1.5 institutional (ULN), except in patients with Gilbert syndrome, who may enroll if total bilirubin is ≤ 3 x institutional ULN and direct bilirubin is ≤ 1.5 x institutional ULN
  • (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotranferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3 x institutional ULN
  • (GFR) ≥ 45 mL/min/1.73 m\^2
  • Participants must be willing to undergo baseline and on-treatment tumor and must have a lesion considered safely accessible for biopsy by the procedural team. Biopsies may be obtained from soft tissue or bone lesions, although soft tissue biopsy is preferred when feasible
  • Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
  • Patients must have disease evaluable for the primary FDG PET metabolic response endpoint, defined as at least one FDG-avid lesion evaluable on baseline FDG PET/CT. The baseline FDG PET/CT must be performed during screening, and the presence of at least one FDG-avid, evaluable lesion must be confirmed prior to registration. RECIST 1.1 is not required for eligibility. Patients with RECIST 1.1 measurable disease will be evaluable for RECIST-based secondary response assessments
  • (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  • Patients with a history of virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the regimen are eligible for this trial
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the Functional Classification. To be eligible for this trial, patients should be class II or better. Participants must have Fridericia's formula- interval (QTcF) ≤ 480 msec based on screening
  • The effects of DSP-5336 (enzomenib) on the developing human fetus are unknown. For this reason and because menin inhibitors agents are known to be teratogenic, men must agree to use adequate (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman suspect she is pregnant while her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of DSP-5336 (enzomenib) administration. Participants should not donate sperm for the duration of study participation, and 6 months after completion of the last dose of study drug

Exclusion criteria

Exclusion Criteria:

  • Prior treatment with a menin inhibitor (any compound targeting the menin-MLL complex)
  • Untreated, symptomatic, active, or progressive
  • Inability or unwillingness to undergo FDG and PSMA PET/CT imaging, including inability to lie flat for > 30 minutes. Patients with uncontrolled diabetes mellitus are not eligible if fasting blood glucose cannot be controlled to ≤ 200 mg/dL, or to the institutional threshold required for interpretable FDG PET/CT imaging, despite appropriate medical management
  • Known to DSP-5336 (enzomenib) or any of its
  • Patients who have received systemic anticancer therapy, including oral anticancer therapy, chemotherapy, radioligand therapy, immunotherapy, targeted therapy, investigational anticancer agents, or other investigational agents, within 5 half-lives or 14 days, whichever is shorter, prior to initiation of study treatment. Longer washout may be required when clinically appropriate based on unresolved toxicity or prolonged expected pharmacodynamic effect. Patients who have received external beam radiation therapy within 2 weeks prior to initiation of study treatment are not eligible. Routine concomitant medications are permitted unless otherwise prohibited by the protocol. Ongoing androgen deprivation therapy with a GnRH agonist or antagonist is permitted
  • Concomitant use of medications known to cause that cannot be safely discontinued or substituted prior to initiation of study treatment
  • Patients with uncontrolled intercurrent illness or any other significant condition(s), including active infection requiring intravenous systemic therapy, that would make participation in this protocol unreasonably hazardous
Terms in these criteria, in plain language(28)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Karnofsky performance status (KPS)

A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.

Studies often ask for 60 or 70 and above. Your doctor gives the score.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (estimated)

Study arms

  • Experimental
    Treatment (androgen deprivation therapy, enzomenib)

    Patients continue to receive usual androgen deprivation therapy per standard of care. Patients receive enzomenib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection, FDG PET/CT, PSMA PET/CT, CT, bone scan and tissue biopsy throughout the study.

    Drug: Antiandrogen Therapy · Procedure: Biopsy Procedure · Procedure: Biospecimen Collection · Procedure: Bone Scan · Procedure: Computed Tomography · Drug: Enzomenib · Procedure: FDG-Positron Emission Tomography · Other: Fludeoxyglucose F-18 · Procedure: PSMA PET Scan

Interventions

  • DrugAntiandrogen Therapy

    Given usual androgen deprivation therapy

    Also known as: ADT, Androgen Deprivation Therapy, Androgen Deprivation Therapy (ADT), Anti-androgen Therapy, Anti-androgen Treatment, Antiandrogen Treatment, Hormone Deprivation Therapy, Hormone-Deprivation Therapy

  • ProcedureBiopsy Procedure

    Undergo tissue biopsy

    Also known as: Biopsy, BIOPSY_TYPE, Bx

  • ProcedureBiospecimen Collection

    Undergo blood sample collection

    Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

  • ProcedureBone Scan

    Undergo bone scan

    Also known as: Bone Scintigraphy

  • ProcedureComputed Tomography

    Undergo CT, FDG PET/CT, and PSMA PET/CT

    Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

  • Given PO

    Also known as: DSP 5336, DSP-5336, DSP5336, Menin Inhibitor DSP-5336, Menin-MLL Interaction Inhibitor DSP-5336

  • ProcedureFDG-Positron Emission Tomography

    Undergo FDG PET/CT

    Also known as: FDG, FDG-PET, FDG-PET Imaging

  • OtherFludeoxyglucose F-18

    Given FDG

    Also known as: 18FDG, FDG, Fludeoxyglucose (18F), fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

  • ProcedurePSMA PET Scan

    Undergo PSMA PET/CT

    Also known as: Prostate-specific Membrane Antigen PET, PSMA PET, PSMA-Positron emission tomography

06

What researchers measure

Primary outcomes

  1. Fluorodeoxyglucose (FDG) positron emission tomography metabolic response rate

    Will be defined as the proportion of patients achieving a ≥ 30% reduction from baseline in total FDG uptake (standardized uptake value \[SUVtotal\]) across all FDG-avid lesions. The response rate will be estimated along with its exact 95% confidence interval (CI).

    Time frame: Up to 12 months

Secondary outcomes

  1. Incidence of adverse events

    Will be graded according to current Cancer Therapy Evaluation Program-required Common Terminology Criteria for Adverse Events version. Will be summarized by type, grade, seriousness, attribution, and relationship to study treatment.

    Time frame: Up to 30 days after last dose of study treatment

  2. Overall response rate

    Will be evaluated using Response Evaluation Criteria in Solid Tumors version 1.1 and Prostate Cancer Working Group 3 (PCWG3). Will be reported with exact 95% CI where applicable. Will be summarized using Kaplan-Meier methods when appropriate.

    Time frame: Up to 12 months

  3. Radiographic progression-free survival (PFS)

    Will be summarized using Kaplan-Meier methods when appropriate.

    Time frame: Up to 12 months

  4. Prostate specific antigen (PSA)-PFS

    Will be summarized using Kaplan-Meier methods when appropriate.

    Time frame: Up to 12 months

  5. Duration of response (DOR)

    Kaplan-Meier estimates of median DOR and 95% CIs will be provided.

    Time frame: From first documented response to radiographic or clinical progression, or death, assessed up to 12 months

  6. Time to PSA progression

    Progression will be assessed using PCWG3. Will be summarized using Kaplan-Meier methods.

    Time frame: From treatment initiation to confirmed PSA progression, will be assessed up to 12 months

  7. Overall survival (OS)

    Will be summarized using Kaplan-Meier estimates, including median OS and 95% CIs.

    Time frame: From treatment initiation to death from any cause, assessed up to 12 months

  8. Tumor response signatures

    Bulk ribonucleic sequencing will be evaluated for transcriptome changes. Will be summarized using Kaplan-Meier methods when appropriate.

    Time frame: Up to 12 months

  9. DSP-5336 (enzomenib) pharmacokinetics (PK)

    PK parameters will be summarized descriptively, and exploratory exposure-safety and exposure-response relationships may be evaluated.

    Time frame: Up to 12 months

Other outcomes

  1. Tumor signatures

    Mutations identified by whole exome sequencing (WES) will focus on the PI3K/AKT/mTOR pathway and common alterations associated with prostate cancer, lineage plasticity, and therapeutic resistance. Paired baseline and on-treatment tumor samples will be used to assess pharmacodynamic changes in transcriptional programs and AKT pathway signaling. Baseline tumor WES with matched germline deoxyribonucleic acid (DNA) will be used to characterize genomic alterations in the enrolled population.

    Time frame: Up to 12 months

  2. Change in variant allele frequencies of tumor mutations in circulating tumor DNA (ctDNA)

    Will be compared to pretreatment. Serial ctDNA dynamics will be explored for association with metabolic response, radiographic response/progression, and clinical outcomes. Given the sample size, correlative analyses will be hypothesis-generating.

    Time frame: At cycle 3 (cycle length = 28 days)

  3. Change in FDG uptake (SUVtotal) in prostate-specific membrane antigen (PSMA)-positive and PSMA-negative lesions

    Exploratory imaging analyses will evaluate metabolic response globally and, when feasible, by lesion phenotype, including PSMA-positive and PSMA-negative lesions. Lesion-level analyses will be descriptive and exploratory, with attention to within-patient heterogeneity.

    Time frame: Up to 12 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Yes — NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Data sharing details ↗ · grants.nih.gov

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07914855
Responsible party
Sponsor
First posted
Nov 4, 2026
Start date
Feb 26, 2027 (estimated)
Primary completion
Jan 4, 2029 (estimated)
Completion
Jan 4, 2029 (estimated)
Last update
Nov 4, 2026

Study contacts

Adel Mandl
principal investigator · JHU Sidney Kimmel Comprehensive Cancer Center LAO

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Enzomenib

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