Table 2.
Trials looking at novel therapies in advanced prostate cancer
| Trial number | Phase | Intervention arm(s) | Population | Outcome | Status |
| CAR T | |||||
| NCT04227275 | 1 | CART-PSMA-TGFβRDN | mCRPC after progression on 2 NHAs | DLT, safety | Active, not recruiting |
| NCT03089203 | 1 | CART-PSMA-TGFβRDN | mCRPC after progression on ≥ 1 systemic therapy | Safety | Active, recruiting |
| NCT04053062 | 1 | LIGHT-PSMA-CART | mCRPC after progression on Abiraterone and chemotherapy | Safety | Suspended |
| NCT04249947 | 1 | P-PSMA-101 CAR-T | mCRPC | ORR, DLT, safety | Active, not recruiting |
| NCT03873805 | 1 | Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes | PSCA+ mCRPC | DLT, safety | Active, recruiting |
| NCT02744287 | 1/2 | BPX-601 (PSCA-specific CAR-T cells) | PSCA+ mCRPC | DLT, safety | Active, recruiting |
| NCT03013712 | 1/2 | EpCAM-specific CAR T Cells | EpCAM+ mCRPC | Safety | Unknown |
| BiTE | |||||
| NCT04104607 | 1 | CC-1 (PSMAxCD3) | mCRPC after progression on ≥ 3 systemic therapies | Safety | Active, recruiting |
| NCT03792841 | 1 | Acapatamab (PSMAxCD3) | mCRPC after progression on 1 NHA and 1 chemotherapy | DLT, safety | Active, not recruiting |
| NCT01140373 | 1/2 | HPN424 (PSMAxCD3) | mCRPC after progression on ≥ 2 systemic therapies | ORR, DLT | Active, not recruiting |
| NCT03972657 | 1/2 | REGN5678 (PSMAxCD28) + Cemiplimab | mCRPC after progression on ≥ 2 systemic therapies | ORR, DLT, safety | Active, recruiting |
| NCT04221542 | 1 | AMG 509 (STEAP1xCD3) | mCRPC after progression on 1 NHA and 1 chemotherapy | DLT, safety | Active, recruiting |
| NCT03406858 | 2 | HER2Bi-armed activated T cells (HER2xCD3) + Pembrolizumab | mCRPC | PFS | Active, not recruiting |
DLT: dose limiting toxicity; EpCAM: Epithelial cell adhesion molecule; mCRPC: metastatic castration-resistant prostate cancer; NHAs: novel hormonal agents; ORR: objective response rate; PFS: progression-free survival; PSCA: prostate stem cell antigen.