Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 2:36 PM
Study NCT ID:
NCT04033432
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2019-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
sEphB4-HSA in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
Sponsor:
Northwestern University
Organization:
Study Overview
Official Title:
A Phase II Study of sEphB4-HSA in Metastatic Castration-Resistant Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this phase II, single-arm, open-label, three center study is to evaluate the efficacy, safety, and tolerability of sEphB4-HSA in patients with mCRPC (metastatic castration-resistant prostate cancer). The study drug, sEphB4-HAS, is a form of protein that has not been approved for sale by the United States Food and Drug Administration (FDA). The study drug prevents tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.
Detailed Description:
PRIMARY OBJECTIVES:
I. To estimate the efficacy of recombinant EphB4-HSA fusion protein (sEphB4-HSA) in patients with metastatic castration resistant prostate cancer (mCRPC) as measured by confirmed prostate specific antigen (PSA) response rate.
SECONDARY OBJECTIVES:
I. The safety and tolerability of sEphB4-HSA in patients with mCRPC according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
II. To assess the time to PSA progression. III. To assess overall response rate in patients with measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG3) (bone) criteria.
IV. To assess radiological progression free survival (rPFS) using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria.
EXPLORATORY OBJECTIVES:
I. To explore molecular changes associated with EphB4 and ephrinB2 expression in tumor specimens (primary and/or metastatic tissue).
II. To explore association of response with molecular biomarkers including aberrations in the PI3K pathway, MYC and TP53.
III. To assess immune cell infiltration of tumors in biopsies. IV. To assess circulating immune changes associated with treatment.
OUTLINE:
Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study.
After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 1 year.
I. To estimate the efficacy of recombinant EphB4-HSA fusion protein (sEphB4-HSA) in patients with metastatic castration resistant prostate cancer (mCRPC) as measured by confirmed prostate specific antigen (PSA) response rate.
SECONDARY OBJECTIVES:
I. The safety and tolerability of sEphB4-HSA in patients with mCRPC according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
II. To assess the time to PSA progression. III. To assess overall response rate in patients with measurable disease using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG3) (bone) criteria.
IV. To assess radiological progression free survival (rPFS) using RECIST 1.1 (soft tissue) and PCWG3 (bone) criteria.
EXPLORATORY OBJECTIVES:
I. To explore molecular changes associated with EphB4 and ephrinB2 expression in tumor specimens (primary and/or metastatic tissue).
II. To explore association of response with molecular biomarkers including aberrations in the PI3K pathway, MYC and TP53.
III. To assess immune cell infiltration of tumors in biopsies. IV. To assess circulating immune changes associated with treatment.
OUTLINE:
Patients receive recombinant EphB4-HSA fusion protein intravenously (IV) over 60 minutes on day 1. Treatment repeats every 14 days for cycles 1-6 and then every 21 days for subsequent cycles. Patients may continue to receive sEphB4-HSA treatment until no longer clinically benefiting (PCWG3), unacceptable toxicity, treatment delay \>= 4 weeks, or prohibitive illness/change in patient?s condition, or patient decides to withdraw from study.
After completion of study treatment, patients are followed up at 30 days and then every 6 months for up to 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-03773 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| STU00209511 | None | None | View | |
| NU 18U10 | OTHER | Northwestern University | View | |
| P30CA060553 | NIH | None | https://reporter.nih.gov/quic… | View |