Table 2.
Updates on previously reported intravenous nanoparticle clinical trials that have not been clinically approved and are currently undergoing clinical trials (not yet recruiting, recruiting, or active)
| Name (company) | Particle type/drug | Investigated application/indication | ClinicalTrials.gov identifiers (phase) | Updates since 2016 |
|---|---|---|---|---|
| Liposomes (cancer) | ||||
| PROMITIL (Lipomedix Pharmaceuticals) |
PEGylated liposomal mitomycin‐C | Solid tumors | 2016: NCT01705002 (Ph I): Completed 2019 additions: NCT03823989 (Ph Ib): Recruiting |
1 new trial 1 trial completed |
| ThermoDox® (Celsion) |
Lyso‐thermosensitive liposomal doxorubicin | Temperature‐triggered doxorubicin release: Breast cancer recurrence at chest wall (microwave hypothermia) Hepatocellular carcinoma (radiofrequency ablation) Liver tumors (mild hypothermia) Refractory solid tumors (magnetic resonance high intensity focused ultrasound) |
2016: NCT02536183 (Ph I): Recruiting NCT00826085 (Ph I/II): Completed NCT02112656 (Ph III): Completed NCT02181075 (Ph I): Completed 2019 additions: NCT03749850 (Ph I): Not yet recruiting |
1 new trial 3 trials completed NCT02181075 (Ph I): Published results highlight how ThermoDox in combination with externally induced mild hyperthermia increase intratumoral concentration of dox by 3.7 times as compared to ThermoDox without hyperthermia induction.26 |
| VYXEOS CPX‐351 (Celator Pharmaceuticals) |
Liposomal formulation of cytarabine:daunorubicin (5:1M ratio) | Leukemias | 2016: NCT01804101 (not provided) NCT02286726 (Ph II) NCT02019069 (Ph II) NCT01943682 (Ph I) NCT02269579 (Ph II) NCT02533115 (Ph IV) NCT01696084 (Ph III) 2019 additions: 21 Total studies |
Received FDA approval in 2017 and EMA approval in 2018 13 new trials |
| Oncoprex (Genprex) |
FUS1 (TUSC2) encapsulated liposome | Lung cancer | 2016: NCT01455389 (Ph I/II): Active, not recruiting |
0 new trials |
| Halaven E7389‐LF (Eisai) |
Liposomal eribulin mesylate | Solid tumors | 2016: NCT01945710 (Ph I): Completed 2019 additions: NCT03207672 (Ph I): Recruiting |
1 new trial 1 trial completed |
| 188Re‐BMEDA‐liposome | 188Re‐N,N‐bis (2‐mercaptoethyl)‐N′,N′‐diethylethylenediamine pegylated liposome | Advanced solid tumors | 2016: NCT02271516 (Ph I): Unknown |
0 new trials |
| Mitoxantrone hydrochloride liposome (CSPC ZhongQi Pharmaceutical Technology) |
Mitoxantrone liposome | Lymphoma and breast cancer | 2016: NCT02131688 (Ph I): Unknown NCT02596373 (Ph II): Recruiting NCT02597387 (Ph II): Recruiting NCT02595242 (Ph I): Withdrawn NCT02597153 (Ph II): Terminated (only one subject enrolled in 1.5 years) 2019 additions: NCT03776279 (Ph I): Recruiting |
1 new trial 1 trial withdrawn 1 trial terminated |
| JVRS‐100 | Cationic liposome incorporating plasmid DNA complex for immune system stimulation | Leukemia | 2016: NCT00860522 (Ph I): Completed |
0 new trials 1 trial completed |
| Lipocurc (SignPath Pharma) |
Liposomal curcumin | Solid tumors | 2016: NCT02138955 (Ph I/II): Unknown |
0 new trials 1 trial changed to unknown status |
| LiPlaCis (LiPlasome Pharma) |
Liposomal formulated cisplatin with specific degradation‐controlled drug release via phospholipase A2 (PLA2) | Advanced or refractory tumors | 2016: NCT01861496 (Ph I): Recruiting |
0 new trials |
| MM‐302 (Merrimack Pharmaceuticals) |
HER2‐targeted liposomal doxorubicin (PEGylated) | Breast cancer | 2016: NCT01304797 (Ph I): Unknown NCT02213744 (Ph II/III): Terminated (felt not to show benefit over control per DMC and confirmed via futility analysis) 2019 additions: NCT02735798 (Ph I): Withdrawn (the study was not started due to the sponsor choosing to not fund the trial) |
1 new trial that was withdrawn 1 trial terminated 1 trial changed to unknown status Merrimack halted the phase II study of MM‐302 (NCT02213744) due to it being unlikely that MM‐302 would demonstrate benefits over the control comparison.27 Merrimack published results for NCT01304797 where data suggested that a tracer nanoparticle could be used to select for patients that exhibit enhanced EPR effect as a means to screen for patients who would likely respond favorably to nanomedicines.28 |
| LIPUSU® (Nanjing Luye Sike Pharmaceutical Co., Ltd.) |
Paclitaxel liposome | Advanced solid tumors, or gastric, breast cancer | 2016: NCT01994031 (Ph IV): Unknown NCT02142790 (Ph IV): Unknown NCT02163291 (Ph II): Unknown NCT02142010 (not provided): Unknown 2019 additions: NCT02996214 (Ph IV): Not yet recruiting |
1 new trial |
| Liposomes (gene therapy: Cancer) | ||||
| TKM‐080301 (Arbutus Biopharma) |
Lipid particle targeting polo‐like kinase 1 (PLK1) for delivery of siRNA | Hepatocellular carcinoma | 2016: NCT02191878 (Ph I/II): Completed |
0 new trials 1 trial completed |
| siRNA‐EphA2‐DOPC | siRNA liposome for EphA2 knockdown | Solid tumors | 2016: NCT01591356 (Ph I): Recruiting |
0 new trials |
| PNT2258 (ProNAi Therapeutics) |
Proprietary single‐stranded DNAi (PNT100) encapsulated in lipid nanoparticles | Lymphomas | 2016: NCT02378038 (Ph II): Terminated NCT02226965 (Ph II): Unknown NCT01733238 (Ph II): Completed |
0 new trials 1 trial completed 1 trial terminated 1 trial changed to unknown status |
| BP1001 (Bio‐Path Holdings) |
Growth factor receptor bound protein‐2 (Grb‐2) antisense oligonucleotide encapsulated in neutral liposomes | Leukemias | 2016: NCT01159028 (Ph I): Active, not recruiting 2019 additions: NCT02923986 (Ph I): Recruiting NCT02781883 (Ph II): Recruiting |
2 new trials |
| DCR‐MYC (Dicerna Pharmaceuticals) |
DsiRNA lipid nanoparticle for NYC oncogene silencing | Solid tumors, multiple myeloma, lymphoma, or hepatocellular carcinoma | 2016: NCT02110563 (Ph I): Terminated (sponsor decision) NCT02314052 (Ph I/II) terminated (sponsor decision) |
0 new trials 2 trials terminated DCR‐MYC development discontinued.29 |
| Atu027 (Silence Therapeutics GmbH) |
AtuRNAi liposomal formulation for PKN3 knockdown in vascular endothelium | Pancreatic cancer | 2016: NCT01808638 (Ph I/II): Completed |
0 new trials 1 trial completed |
| SGT‐53 (SynerGene Therapeutics) |
Cationic liposome with anti‐transferrin receptor antibody, encapsulating wildtype p53 sequence | Glioblastoma, solid tumors, or pancreatic cancer | 2016: NCT02354547 (Ph I): Recruiting NCT02354547 (Ph I): Recruiting NCT02340156 (Ph II): Recruiting NCT00470613 (Ph I): Completed 2019 additions: NCT03554707 (Ph I): Not yet recruiting |
1 new trial 1 trial completed |
| SGT‐94 (SynerGene Therapeutics) |
RB94 plasmid DNA in a liposome with anti‐transferrin receptor antibody | Solid tumors | 2016: NCT01517464 (Ph I): Completed |
0 new trials 1 trial completed |
| MRX34 (Mirna Therapeutics) |
Double‐stranded RNA mimic of miR‐34 encapsulated in liposomes | Liver cancer | 2016: NCT01829971 (Ph I): Terminated (five immune related serious adverse events) 2019 additions: NCT02862145 (Ph I): Withdrawn (5 immune related serious adverse events in phase 1 study) |
1 new trial that was withdrawn 1 trial terminated |
| TargomiRs (EnGeneIC) |
Anti‐EGFR bispecific antibody minicells (bacteria derived nanoparticles) with a miR‐16 based microRNA payload | Mesothelioma and non‐small cell lung cancer | 2016: NCT02369198 (Ph I): Completed |
0 new trials 1 trial completed NCT02369198 (Ph I): Published study demonstrates that TargomiRs were well‐tolerated by refractory malignant pleural mesothelioma patients.30 |
| Liposomes (gene therapy: Other) | ||||
| ND‐L02‐s0201 (Nitto Denko) |
siRNA lipid nanoparticle conjugated to vitamin A | Hepatic fibrosis and pulmonary fibrosis | 2016: NCT02227459 (Ph I): Completed 2019 additions: NCT01858935 (Ph I): Completed NCT03241264 (Ph I): Completed NCT03538301 (Ph II): Recruiting |
3 new trials (2 completed) 1 trial completed |
| ARB‐001467 TKM‐HBV (Arbutus Biopharma) |
Lipid particle containing three RNAi therapeutics that target three sites on the HBV genome | Hepatitis B | 2016: NCT02631096 (Ph II): Completed |
0 new trials 1 trial completed |
| ONPATTRO Patisiran ALN‐TTR02 (Alnylam Pharmaceuticals) |
Lipid nanoparticle RNAi for the knockdown of disease‐causing TTR protein | Transthyretin (TTR)‐mediated amyloidosis | 2016: NCT02510261 (Ph III) NCT01961921 (Ph II) NCT01960348 (Ph III) 2019 additions: 11 total studies |
Received FDA and EMA approval in 2018 |
| Liposomes (other) | ||||
| CAL02 (Combioxin SA) |
Sphingomyelin and cholesterol liposomes for toxin neutralization | Pneumonia | 2016: NCT02583373 (Ph I): Completed |
0 new trials 1 trial completed |
| Nanocort (Enceladus in collaboration with sun pharma global) |
Liposomal prednisolone (PEGylated) | Rheumatoid arthritis and hemodialysis fistula maturation | 2016: NCT02495662 (Ph II): Terminated (slow inclusion) NCT02534896 (Ph III): Terminated |
0 new trials 2 trials terminated |
| RGI‐2001 (Regimmune) |
Liposomal formulaton of α‐GalCer | Mitigating graft versus host disease following stem cell transplant | 2016: NCT01379209 (Ph I/II): Unknown 2019 additions: NCT04014790 (Ph II): Not yet recruiting |
1 new trial |
| Sonazoid | F‐butane encapsulated in a lipid shell | Contrast enhanced ultrasound for imaging hepatocellular carcinoma, skeletal muscle perfusion, or for estimating portal hypertension | 2016: NCT00822991 (not provided): Recruiting NCT02398266 (Ph II): Unknown NCT02188901 (not provided): Completed NCT02489045 (Ph IV): Recruiting |
0 new trials 1 trial changed to unknown status 1 trial completed |
| Polymeric and micelles (cancer) | ||||
| AZD2811 (AstraZeneca with BIND Therapeutics) |
Aurora B kinase inhibitor in BIND therapeutics polymer particle accurin platform | Advanced solid tumors | 2016: NCT02579226 (Ph I): Recruiting 2019 additions: NCT03366675 (Ph II): Terminated (early detection of the purpose of the study) NCT03217838 (Ph I): New, recruiting |
2 new trials (1 terminated) |
| BIND‐014 (BIND Therapeutics) |
PSMA targeted (via ACUPA) docetaxel PEG‐PLGA or PLA–PEG particle | Prostate, metastatic, non‐small cell lung, cervical, head and neck, or KRAS positive lung cancers | 2016: NCT02479178 (Ph II): Terminated NCT02283320 (Ph II): Completed NCT01812746 (Ph II): Completed NCT01792479 (Ph II): Completed NCT01300533 (Ph I): Completed |
0 new trials 4 trials completed Pfizer purchased BIND Therapeutics' bankruptcy assets July 2016.31 |
| Cynviloq IG‐001 (Sorrento) |
Paclitaxel polymeric micelle nanoparticle | Breast cancer | 2016: NCT02064829 (not provided): Completed |
0 new trials 1 trial completed |
| Genexol‐PM (Samyang Biopharmaceuticals) |
Paclitaxel polymeric micelle nanoparticle | Head and neck or breast cancer | 2016: NCT01689194 (Ph II): Unknown NCT02263495 (Ph II): Completed NCT00912639 (Ph IV): Unknown 2019 additions: NCT02739633 (Ph II): Recruiting NCT03008512 (Ph II): Recruiting |
2 new trials 1 trial completed 1 trial changed to unknown status |
| NC‐6004 Nanoplatin (Nanocarrier) |
Polyamino acid, PEG, and cisplatin derivative micellar nanoparticle | Advanced solid tumors, lung, biliary, bladder, or pancreatic cancers | 2016: NCT02240238 (Ph I/II): Active, not recruiting NCT02043288 (Ph III): Unknown 2019 additions: NCT03771820 (Ph II): Not yet recruiting NCT03109158 (Ph I): Completed NCT02817113 (Ph I): Unknown |
3 new trials 1 trial changed to unknown status |
| NC‐4016 DACH‐Platin micelle (Nanocarrier) |
Polyamino acid, PEG, and oxaliplatin micellar nanoparticle | Advanced solid tumors or lymphomas | 2016: NCT01999491 (Ph I): Completed |
0 new trials |
| NK105 (Nippon Kayaku) |
Paclitaxel micelle | Breast cancer | 2016: NCT01644890 (Ph III): Completed |
0 new trials 1 trial completed |
| Docetaxel‐PM DOPNP201 (Samyang Biopharmaceuticals) |
Docetaxel micelle | Head and neck cancer and advanced solid tumors | 2016: NCT02639858 (Ph II): Recruiting NCT02274610 (Ph I): Completed 2019 additions: NCT03585673 (Ph II): Recruiting |
1 new trial 1 trial completed |
| CriPec (Cristal Therapeutics) |
Docetaxel micelles | Solid tumors, ovarian cancer | 2016: NCT02442531 (Ph I): Completed 2019 additions: NCT03712423 (Ph I): Recruiting NCT03742713 (Ph II): Recruiting |
2 new trials 1 trial completed |
| CRLX101 (Cerulean) |
Cyclodextrin‐based nanoparticle‐camptothecin conjugate | Ovarian, renal cell, small cell lung, or rectal cancers | 2016: NCT02187302 (Ph II): Completed NCT02010567 (Ph I/II): Active, not recruiting NCT02389985 (Ph I): Terminated (company decision) NCT01803269 (Ph II): Terminated (due to lack of activity and slow accrual) NCT01652079 (Ph II): Completed 2019 additions: NCT02769962 (Ph I): Recruiting NCT03531827 (Ph II): Recruiting NCT02648711(Ph I): Terminated (company decision) NCT01380769 (Ph II): Completed NCT01612546 (Ph II): Completed NCT00333502 (Ph II): Completed NCT01625936 (Ph I): Completed NCT00753740 (Ph II): Withdrawn (poor trial recruitment) NCT00163319 (Ph III): Completed |
9 new trials (1 terminated, 1 withdrawn, 5 completed) 2 previous trials completed 2 previous trials terminated NCT02010567 (Ph I/II): Addition of CRLX101 to standard chemoradiotherapy was in locally advanced rectal cancer patients demonstrated well‐tolerability.32 |
| CRLX301 (Cerulean) |
Cyclodextrin based nanoparticle‐docetaxel conjugate | Dose escalation study in advanced solid tumors | 2016: NCT02380677 (Ph I/II): Terminated (company decision) |
0 new trials 1 trial terminated |
| Polymeric and micelles (other) | ||||
| RadProtect (Original BioMedicals) |
PEG, iron, and amifostine micelle Transferrin‐mediated chelation for amifostine release |
Dose escalation and safety for acute radiation syndrome | 2016: NCT02587442 (Ph I): Unknown |
0 new trials |
| Albumin‐bound (cancer) | ||||
| ABI‐009 (Aadi with Celgene) |
Albumin bound rapamycin | Bladder cancer, PEComa, or pulmonary arterial hypertension | 2016: NCT02009332 (Ph I/II): Recruiting NCT02587325 (Ph I): Recruiting NCT02494570 (Ph II): Active not recruiting 2019 additions: NCT03747328 (Ph II): Not yet recruiting NCT03657420 (Ph I): Not yet recruiting NCT03670030 (Ph II): Recruiting NCT03646240 (Ph I): Recruiting NCT03190174 (Ph I): Recruiting NCT00635284 (Ph I): Completed NCT03817515: Expanded access status: Available NCT03439462 (Ph II): Recruiting NCT03463265 (Ph II): Recruiting NCT03660930 (Ph I): Recruiting NCT02975882 (Ph I): Recruiting NCT02646319 (Ph I): Completed |
12 new trials (2 completed) |
| ABI‐011 (NantBioScience) |
Albumin bound thiocolchicine analog (IDN 5405) | Solid tumors or lymphomas | 2016: NCT02582827 (Ph I): Recruiting |
0 new trials |
| Inorganic (cancer) | ||||
| AuroLase (Nanospectra Biosciences) |
PEG‐coated silica‐gold nanoshells for near infrared light facilitated thermal ablation | Thermal ablation of solid primary and/or metastatic lung tumors | 2016: NCT01679470 (not provided): Terminated 2019 additions: NCT02680535 (not provided): Recruiting NCT00848042 (not provided): Completed |
2 new trials (1 completed) 1 trial terminated |
| NBTXR3 PEP503 (Nanobiotix) |
Hafnium oxide nanoparticles stimulated with external radiation to enhance tumor cell death via electron production | Locally advanced squamous cell carcinoma | 2016: NCT01946867 (Ph I): Unknown 2019 additions: NCT02721056 (Ph II): Unknown NCT02805894 (Ph II): Recruiting NCT03589339 (Ph II): Not yet recruiting NCT02379845 (Ph II): Active not recruiting NCT02901483 (Ph I): Recruiting NCT02465593 (Ph I): Recruiting |
Received CE mark approval in 2019 6 new trials 1 trial changed to unknown status |
| Cornell Dots | Silica nanoparticles with a NIR fluorophore, PEG coating, and a 124I radiolabeled cRGDY targeting peptide | Imaging of melanoma and malignant brain tumors | 2016: NCT01266096 (not provided): Active, not recruiting 2019 additions: NCT03465618 (Ph I): Recruiting NCT02106598 (Ph II): Recruiting |
2 new trials |
| Magnablate | Iron nanoparticles | Thermal ablation for prostate cancer | 2016: NCT02033447 (Ph 0): Completed |
0 new trials 1 trial completed |
Note: These trials are grouped by particle type and inidication. Modified with permission from Reference 1.
Abbreviations: EMA, European Medicines Agency; FDA, Food and Drug Administration.