Trial · NCT04033432
sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
NCT04033432, Phase 2, Unknown, Northwestern University; results first posted 2022-04-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer. Trials, record NCT04033432. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04033432
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
- NCT number
- NCT04033432
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
Castration Levels of Testosterone, Castration-Resistant Prostate Carcinoma, Castration-Resistant Prostate Carcinoma Refractory to Second-Generation Androgen Receptor Axis-Targeted Agents, Metastatic Prostate Adenocarcinoma, Progressive Disease, Prostate Carcinoma Metastatic in the Bone, Prostate Carcinoma Metastatic in the Soft Tissue, PSA Progression, Stage IVB Prostate Cancer AJCC v8, Testosterone Less Than 50 ng/dL
- Interventions
- Recombinant EphB4-HSA Fusion Protein
- First posted
- 2019-07-26
- Last updated
- 2022-04-27
- Results first posted
- 2022-04-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Prostate Specific Antigen (PSA) Response Rate | Up to 1 year | Assessment of confirmed PSA response rate is the proportion of subjects who received at least 1 dose of the study drug achieving a post-treatment PSA partial response or complete response as defined by PSA response criteria. PSA response criteria: These definitions are intended to characterize the PSA changes on study for the purpose of reporting of results. Complete Response (CR): Undetectable PSA (\<0.2 ng/ml) that is confirmed by another PSA level at no less than 4 weeks interval (+/- 3 days). Partial Response (PR): Decrease in PSA value by \> 50% that is confirmed by another PSA level at no less than 4 weeks interval (+/- 3 days). Stabilization(SD): Patients who do not meet the criteria or PR or PD for at least90 days on the study will be considered stable Progression (PD): 25% increase over baseline or nadir whichever is lower and an increase in the absolute value of PSA level by2 ng/ml that is confirmed by another PSA level at no less than 4 weeks interval. |
| Secondary | Incidence of Adverse Events | Up to 1 year | Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and reported by the toxicity, severity, and attribution will be recorded for each cycle. All reported adverse event (AE) types will be tabulated by maximum grade using frequencies and percentages. Data on type, timing, frequency and attribution of AEs will also be summarized. |
| Secondary | Time to PSA Progression | From the start of study treatment to PSA progression, assessed for up to 1 year | The time to PSA progression will be assessed by calculating the interval from administration of the first dose of drug on cycle 1 day 1 to PSA progression. PSA progression is defined by the criteria. PSA will be assessed every odd cycle. Will use Kaplan Meier methods to estimate the distribution of time to PSA progression. Will estimate the median with two-sided 90% confidence interval (CI). |
| Secondary | Overall Response Rate | Up to 1 year | The overall response rate will be the proportion of patients with measurable disease who received at least 1 dose of the study drug and as their best response achieved a partial or complete response (responder). Will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and PCWG3 criteria. Will be reported with two-sided 90% exact binomial CI. |
| Secondary | Time to Radiologic Progression (rPFS) | From the start of study treatment to the time of radiologic progression or death from any cause, assessed for up to 1 year | The time to rPFS will be assessed by calculating the interval from administration of the first dose of drug on cycle 1 day 1 to the time to radiologic progression by RECIST 1.1 or PCWG3 bone criteria or death from any cause. Radiologic assessment will be every 8 weeks. Will use Kaplan Meier methods to estimate the distribution of rPFS. Will estimate the median with two-sided 90% confidence interval (CI). |
| Other | Changes in EphB4 and ephrinB2 Expression | Baseline up to 1 year | EphB4 and ephrinB2 expression will be assessed by immunohistochemistry (IHC) staining of primary and/or metastatic site (recent archival specimen or new biopsy). EphB4 and other biomarker abnormalities will be assessed by next generation sequencing of metastatic tissue. Will explore if PSA response is associated with expression of EphB4 and ephrinB2 in archival metastatic and primary tumor CRPC specimens. Summaries will be descriptive and graphical. |
| Other | Circulating Tumor-derived Deoxyribonucleic Acid (ctDNA) Analysis of PI3K Pathway, MYC or TP53 | Up to 1 year | ctDNA will be analyzed for abnormalities in PI3K pathway, MYC or TP53. Summaries will be descriptive and graphical. |
| Other | Immune Infiltrate Characterization in Tumor Specimen | Up to 1 year | The study will use IHC for CD3, CD4, CD8, and natural-killer cell markers to characterize the immune infiltrate in tumor specimen. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Prostate Specific Antigen (PSA) Response Rate | Up to 1 year | From the 14 patients whose PSA data was provided, 14 patients in the sample met the criteria to be assessed for PSA response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence of Adverse Events | Up to 1 year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to PSA Progression | From the start of study treatment to PSA progression, assessed for up to 1 year | Of the 14 eligible patients, 14 experienced disease progression by the end of their participation in the study, where progression included events as indicated by PSA values or with a known outcome of death by the time of follow-up. In accordance with the study protocol, a median value for days to progression.~was calculated along with the 95% confidence interval. | Days | MEDIAN |
| SECONDARY | Overall Response Rate | Up to 1 year | From the 14 patients whose RECIST data was provided, 3 patients in the sample met the criteria to be assessed for RECIST response (receive at least one dose of treatment, have measurable disease). Of the 3 eligible patients, 1 reported tumor progression as his best overall response while 2 patients experienced stabilization as their best overall response. No best overall responses were categorized as partial or complete drug response. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Radiologic Progression (rPFS) | From the start of study treatment to the time of radiologic progression or death from any cause, assessed for up to 1 year | Days | MEDIAN | |
| OTHER_PRE_SPECIFIED | Changes in EphB4 and ephrinB2 Expression | Baseline up to 1 year | |||
| OTHER_PRE_SPECIFIED | Circulating Tumor-derived Deoxyribonucleic Acid (ctDNA) Analysis of PI3K Pathway, MYC or TP53 | Up to 1 year | |||
| OTHER_PRE_SPECIFIED | Immune Infiltrate Characterization in Tumor Specimen | Up to 1 year |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Prostate Specific Antigen (PSA) Response Rate | Treatment (Recombinant EphB4-HSA Fusion Protein) | Progressive Disease | 13 | Participants | |
| Prostate Specific Antigen (PSA) Response Rate | Treatment (Recombinant EphB4-HSA Fusion Protein) | Non-Evaluable | 1 | Participants | |
| Incidence of Adverse Events | Treatment | 14 | Participants | ||
| Time to PSA Progression | Treatment | 28 | 95% Confidence Interval 28 to 64 | Days | |
| Overall Response Rate | Treatment | Stable Disease | 2 | Participants | |
| Overall Response Rate | Treatment | Progressive Disease | 1 | Participants | |
| Time to Radiologic Progression (rPFS) | Treatment (Recombinant EphB4-HSA Fusion Protein) | 55 | 90% Confidence Interval 55 to NA | Days |
Source ClinicalTrials.gov
Participant flow11
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment | 14 | |
| Overall Study | Registered for Study | Treatment | 14 | |
| Overall Study | Started Cycle 1 | Treatment | 14 | |
| Overall Study | Started Cycle 2 | Treatment | 13 | |
| Overall Study | Started Cycle 3 | Treatment | 10 | |
| Overall Study | Started Cycle 4 | Treatment | 7 | |
| Overall Study | Started Cycle 5 | Treatment | 1 | |
| Overall Study | Started Cycle 6 | Treatment | 1 | |
| Overall Study | Started Cycle 7+ | Treatment | 1 | |
| Overall Study | COMPLETED | Treatment | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 participant flowAdverse events81
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 |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | Treatment | 2 | 14 | 2 |
| other | Alkaline phosphate increase | Investigations | Treatment | 9 | 14 | 12 |
| other | Anaphylaxis | Immune system disorders | Treatment | 1 | 14 | 1 |
| other | Anemia | Cardiac disorders | Treatment | 7 | 14 | 11 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment | 3 | 14 | 4 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment | 1 | 14 | 1 |
| other | Aspartate aminotransferase increased | Investigations | Treatment | 7 | 14 | 9 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Treatment | 1 | 14 | 1 |
| other | Blood bicarbonate decrease | Investigations | Treatment | 2 | 14 | 2 |
| other | Blood bilirubin increase | Investigations | Treatment | 1 | 14 | 1 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment | 2 | 14 |
| Total, other adverse events | Treatment | 14 | 14 |
| Total, serious adverse events | Treatment | 3 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36210299 | DERIVED |
Source PubMed
Grants1
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 |
|---|---|---|---|---|---|
| P30CA060553 | The Robert H. Lurie Comprehensive Cancer Center | PLATANIAS, LEONIDAS C. | NORTHWESTERN UNIVERSITY | NATIONAL CANCER INSTITUTE | 1993 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04033432
GET https://conductscience.org/api/trials/v1/NCT04033432/events?page=2