Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer
NCT07914855, Phase 2, Not yet recruiting, National Cancer Institute (NCI)
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Testing the Anti-cancer Drug DSP-5336 (Enzomenib) in Prostate Cancer | ClinicalTrials.gov |
| NCT number | NCT07914855 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 24 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National Cancer Institute (NCI) | ClinicalTrials.gov |
| Conditions | Metastatic Castration-Resistant Prostate Adenocarcinoma, Stage IVB Prostate Cancer AJCC v8 | ClinicalTrials.gov |
| Interventions | Antiandrogen Therapy, Biopsy Procedure, Biospecimen Collection, Bone Scan, Computed Tomography, Enzomenib, FDG-Positron Emission Tomography, Fludeoxyglucose F-18, PSMA PET Scan | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Fluorodeoxyglucose (FDG) positron emission tomography metabolic response rate | Up to 12 months | 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). | ClinicalTrials.gov |
| Secondary | Incidence of adverse events | Up to 30 days after last dose of study treatment | 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. | ClinicalTrials.gov |
| Secondary | Overall response rate | Up to 12 months | 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. | ClinicalTrials.gov |
| Secondary | Radiographic progression-free survival (PFS) | Up to 12 months | Will be summarized using Kaplan-Meier methods when appropriate. | ClinicalTrials.gov |
| Secondary | Prostate specific antigen (PSA)-PFS | Up to 12 months | Will be summarized using Kaplan-Meier methods when appropriate. | ClinicalTrials.gov |
| Secondary | Duration of response (DOR) | From first documented response to radiographic or clinical progression, or death, assessed up to 12 months | Kaplan-Meier estimates of median DOR and 95% CIs will be provided. | ClinicalTrials.gov |
| Secondary | Time to PSA progression | From treatment initiation to confirmed PSA progression, will be assessed up to 12 months | Progression will be assessed using PCWG3. Will be summarized using Kaplan-Meier methods. | ClinicalTrials.gov |
| Secondary | Overall survival (OS) | From treatment initiation to death from any cause, assessed up to 12 months | Will be summarized using Kaplan-Meier estimates, including median OS and 95% CIs. | ClinicalTrials.gov |
| Secondary | Tumor response signatures | Up to 12 months | Bulk ribonucleic sequencing will be evaluated for transcriptome changes. Will be summarized using Kaplan-Meier methods when appropriate. | ClinicalTrials.gov |
| Secondary | DSP-5336 (enzomenib) pharmacokinetics (PK) | Up to 12 months | PK parameters will be summarized descriptively, and exploratory exposure-safety and exposure-response relationships may be evaluated. | ClinicalTrials.gov |
| Other | Tumor signatures | Up to 12 months | 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. | ClinicalTrials.gov |
| Other | Change in variant allele frequencies of tumor mutations in circulating tumor DNA (ctDNA) | At cycle 3 (cycle length = 28 days) | 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. | ClinicalTrials.gov |
| Other | Change in FDG uptake (SUVtotal) in prostate-specific membrane antigen (PSMA)-positive and PSMA-negative lesions | Up to 12 months | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| UM1CA186691 | The Johns Hopkins Translational Science Team and Consortium for ETCTN Studies | CARDUCCI, MICHAEL A; BEUMER, JAN HENDRIK; GENTZLER, RYAN; LIU, GLENN; MESSERSMITH, WELLS A.; RUIZ, JIMMY | JOHNS HOPKINS UNIVERSITY | NATIONAL CANCER INSTITUTE | 2014 to 2025 | NIH RePORTER |
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)