Castration-Resistant Prostate Carcinoma Clinical Trial
Official title:
A Phase II Study of sEphB4-HSA in Metastatic Castration-Resistant Prostate Cancer
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT04716725 -
68Ga-PSMA-11 PET for the Diagnosis of Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03218826 -
PI3Kbeta Inhibitor AZD8186 and Docetaxel in Treating Patients Advanced Solid Tumors With PTEN or PIK3CB Mutations That Are Metastatic or Cannot Be Removed by Surgery
|
Phase 1 | |
Completed |
NCT01881867 -
CYT107 After Vaccine Treatment (Provenge®) in Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Not yet recruiting |
NCT06236139 -
Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
Recruiting |
NCT04071236 -
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT02522715 -
Enzalutamide and Cabazitaxel in Treating Patients With Metastatic, Castration-Resistant Prostate Cancer
|
Phase 1/Phase 2 | |
Terminated |
NCT04951492 -
Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma
|
Phase 2 | |
Active, not recruiting |
NCT04514484 -
Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and HIV
|
Phase 1 | |
Active, not recruiting |
NCT03344211 -
Enzalutamide With or Without Radium Ra 223 Dichloride in Patients With Metastatic, Castration-Resistant Prostate Cancer
|
Phase 2 | |
Active, not recruiting |
NCT02312557 -
Pembrolizumab in Treating Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Enzalutamide
|
Phase 2 | |
Recruiting |
NCT04159896 -
ESK981 and Nivolumab for the Treatment of Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Completed |
NCT05547386 -
68Ga-PSMA-11 PET/CT Screening Prior to 177Lu-PSMA-617 Therapy for Patients With Metastatic Castrate Resistant Prostate Cancer
|
Phase 3 | |
Recruiting |
NCT05960578 -
Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study
|
Phase 2 | |
Recruiting |
NCT06200103 -
Schedule De-Escalation of 177Lu-PSMA-617 for the Treatment of Metastatic Castrate Resistant Prostate Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03517969 -
M6620 and Carboplatin With or Without Docetaxel in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT06039371 -
Supraphysiological Androgen to Enhance Chemotherapy Treatment Activity in Metastatic Castration-Resistant Prostate Cancer, SPECTRA Study
|
Phase 2 | |
Active, not recruiting |
NCT02703623 -
Abiraterone Acetate, Prednisone, and Apalutamide With or Without Ipilimumab or Cabazitaxel and Carboplatin in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT04777071 -
An Investigational Scan (68Ga-PSMA-11 PET) for the Imaging of Prostate Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03805594 -
177Lu-PSMA-617 and Pembrolizumab in Treating Patients With Metastatic Castration-Resistant Prostate Cancer
|
Phase 1 | |
Recruiting |
NCT05730712 -
Pertuzumab, Trastuzumab, Hyaluronidase-zzxf and Enzalutamide for Treatment of Metastatic Castration-Resistant Prostate Cancer
|
Phase 2 |