Prostate Cancer Metastatic Clinical Trial
Official title:
A Phase 1/2 Study of Replicating Arenavirus-based Vector(s) Encoding Prostate Cancer-Associated Antigens in Participants With Metastatic Castration-Resistant Prostate Cancer
This is a first-in-human Phase 1/2, multinational, multicenter, open-label study of HB-302/HB-301 alternating 2-vector therapy in participants with metastatic castration-resistant prostate cancer (mCRPC) comprising 2 phases: a Phase 1 Dose Escalation and recommended Phase 2 dose (RP2D) Confirmation, and a Phase 2 Dose Expansion.
This is a first-in-human Phase 1/2, multinational, multicenter, open-label study of HB-302/HB-301 alternating 2-vector therapy in participants with metastatic castration-resistant prostate cancer (mCRPC) comprising 2 phases: a Phase 1 Dose Escalation and recommended Phase 2 dose (RP2D) Confirmation, and a Phase 2 Dose Expansion. The Phase 1 Dose Escalation will evaluate HB-302/HB-301 alternating 2-vector therapy for safety and tolerability, preliminary efficacy and immunogenicity, and determination of a safe recommended Phase 2 dose (RP2D). A confirmatory cohort (or cohorts) will inform the determination of the RP2D. The Phase 2 Dose Expansion will assess HB-302/HB-301 alternating 2-vector therapy at the RP2D defined in the Phase 1 part of the study. Study drugs HB-301 and HB-302 are genetically-engineered replicating vectors based on the arenavirus lymphocytic choriomeningitis virus (LCMV) and arenavirus Pichinde virus (PICV), respectively. HB-301 and HB-302 express the same transgenes encoding 2 prostate cancer-associated antigens: prostatic acid phosphatase (PAP) and prostate specific antigen (PSA). HB-302/HB-301 Alternating 2-vector therapy will be administered intravenously every 3 weeks (Q3W) for the first 5 doses and every 6 weeks (Q6W) from the fifth dose and onward. HB-302 is to be administered first followed 3 or 6 weeks later by HB-301. In total, approximately 70 participants aged 18 years and older will be enrolled in this study to receive HB-302/HB-301 alternating 2-vector therapy. About 40 Investigators and study sites in the United States (US) and Europe are expected to participate in this study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
| Suspended |
NCT05361915 -
Study to Assess Abivertinib in Combination With Abiraterone in Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
| Recruiting |
NCT05067140 -
A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT03646162 -
Study of VERU-944 to Ameliorate Hot Flashes in Men With Advanced Prostate Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03413995 -
Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations
|
Phase 2 | |
| Recruiting |
NCT05078151 -
Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer
|
N/A | |
| Recruiting |
NCT03507595 -
Evaluation of the Metastasis and Recurrence of Prostate Cancer
|
||
| Completed |
NCT03362359 -
Ga-68-PSMA-11 in High-risk Prostate Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04116775 -
Fecal Microbiota Transplant and Pembrolizumab for Men With Metastatic Castration Resistant Prostate Cancer.
|
Phase 2 | |
| Completed |
NCT03223727 -
Treatment Outcomes in a Non-study Population of Symptomatic mCRPC Patients Treated With Radium-223
|
||
| Recruiting |
NCT04983095 -
Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer
|
Phase 3 | |
| Recruiting |
NCT04086290 -
National Danish Protocol. Surgery+ SBRT for M1 Prostate Cancer Patients
|
Phase 1/Phase 2 | |
| Recruiting |
NCT03129139 -
A Phase 1, Multi-Center, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of Minnelide™ Capsules Given Alone or in Combination With Protein-Bound Paclitaxel in Patients With Advanced Solid Tumors
|
Phase 1 | |
| Active, not recruiting |
NCT04983628 -
Molecular Profiling in Prostate Cancer
|
||
| Active, not recruiting |
NCT03414437 -
Post-eRADicAte - A Long Term Follow up of Subjects That Completed the eRADicAte Study (NCT 02097303)
|
||
| Completed |
NCT02485691 -
Cabazitaxel Versus the Switch to Alternative AR-targeted Agent (Enzalutamide or Abiraterone) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Patients Previously Treated With Docetaxel and Who Rapidly Failed a Prior AR-targeted Agent
|
Phase 4 | |
| Completed |
NCT03693742 -
MSG Use With 18F-DCFPyL PET/CT Imaging
|
N/A | |
| Completed |
NCT01322490 -
A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
|
Phase 3 | |
| Completed |
NCT03739684 -
Study of 18F-DCFPyL PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
|
Phase 3 | |
| Recruiting |
NCT05655715 -
Checkpoint Inhibitors and SBRT for mCRPC
|
Phase 2 |