Table 1.
Current active and recruiting clinical trials with commercial sponsors using targeted alpha therapy.
| Trial Number | Alpha Particle | Target | Agent(s) | Setting | Primary Outcome Measures |
|---|---|---|---|---|---|
| Cornell | |||||
| NCT03276572 | 225Ac | PSMA | 225Ac-J591 | mCRPC treated with prior ARPI | DLT, MTD |
| NCT04506567 | 225Ac | PSMA | 225Ac-J591 | mCRPC treated with prior ARPI | DLT, MTD, RP2D |
| NCT04576871 | 225Ac | PSMA | 225Ac-J591 | mCRPC treated with prior ARPI | DLT |
| NCT04886986 | 225Ac | PSMA | 225Ac-J591 with 177Lu-PSMA-I&T | mCRPC treated with prior ARPI | DLT, MTD, RP2D, PSA decline |
| NCT04946370 | 225Ac | PSMA | 225Ac-J591 with pembrolizumab and ARPI | mCRPC treated with prior ARPI | DLT, RP2D, response rate |
| NCT05567770 | 225Ac | PSMA | 225Ac-J591 | mHSPC | DLT, MTD |
| Fusion Pharmaceuticals | |||||
| NCT03746431 | 225Ac | IGF-1R | 225Ac-FPI-1434 | IGF-1R-positive solid tumors refractory to standard therapies | AE, DLT, ORR |
| NCT05605522 | 225Ac | NTSR1 | 225Ac-FPI-2059 | NTSR1-positive solid tumors refractory to standard therapies | AE, MTD |
| NCT05219500 | 225Ac | PSMA | 225Ac-FPI-2265 (PSMA-I&T) | mCRPC with prior ARPI | PSA50, safety |
| Bayer | |||||
| NCT04147819 | 227Th | HER2 | BAY2701439 | HER2-positive solid tumors refractory to standard therapies | AE, ORR |
| AdvanCell | |||||
| NCT05720130 | 212Pb | PSMA | 212Pb-ADVC001 | mCRPC with prior ARPI and no prior exposure to 177Lu | RP2D |
| Novartis | |||||
| NCT04597411 | 225Ac | PSMA | 225Ac-PSMA-617 | mCRPC | RP2D |
| Janssen | |||||
| NCT04644770 | 225Ac | hK2 | 225Ac-DOTA-h11B6 (JNJ-69086420) | mCRPC with prior ARPI | AE, DLT |
| Radiomedix and Orano Med | |||||
| NCT03466216 | 212Pb | SSTR2 | 212Pb-DOTAMTATE | SSTR2-positive neuroendocrine tumors refractory to standard therapies | DLT, MTD |
| NCT05153772 | 212Pb | SSTR2 | 212Pb-DOTAMTATE | SSTR2-positive neuroendocrine tumors refractory to standard therapies | ORR, AE |
| RayzeBio | |||||
| NCT05477576 | 225Ac | SSTR2 | RYZ101 | SSTR2-positive gastroenteropancreatic neuroendocrine tumors with prior 177Lu therapy | RP3D, PFS |
| NCT05595460 | 225Ac | SSTR2 | RYZ101 with carboplatin, etoposide, and atezolizumab | SSTR2-positive extensive-stage small-cell lung cancer | RP2D, safety, tolerability |
| Orano Med | |||||
| NCT05283330 | 212Pb | GRPR1 | 212Pb-DOTAM-GRPR1 | GRPR1-positive solid tumors refractory to standard therapies | RP2D |
| Actinium Pharmaceuticals | |||||
| NCT03441048 | 225Ac | CD33 | 225Ac-lintuzumab with cladribine, cytarabine, filgrastim, and mitoxantrone | Relapsed/refractory AML | DLT, MTD, AE, OS |
| NCT03867682 | 225Ac | CD33 | 225Ac-lintuzumab with venetoclax | Relapsed/refractory AML | MTD, overall response |
Abbreviations: PSMA, prostate-specific membrane antigen; mCRPC, metastatic castration-resistant prostate cancer; ARPI, androgen-receptor pathway inhibitor; DLT, dose-limiting toxicities; MTD, maximum tolerated dose; RP2D, recommended phase 2 dose; mHSPC, metastatic hormone-sensitive prostate cancer; IGF-1R, insulin-like growth factor 1 receptor; AE, adverse events; ORR, objective response rate; NTSR1, neurotensin receptor 1; FGFR3, fibroblast growth factor receptor 3; PSA50, PSA decline by at least 50%; hK2, human kallikrein 2; SSTR2, somatostatin receptor type 2; PFS, progression-free survival; RP3D, recommended phase 3 dose; GRPR1, gastrin-releasing peptide receptor; AML, acute myeloid leukemia; OS, overall survival.