Selected clinical trials and approved nanocarrier-based antitumor therapies.
| Nanocarrier/drug | Phase/status | Indication | Key outcomes (Quantitative) | NCT identifier | Sponsor/institution |
|---|---|---|---|---|---|
| Doxil® (Liposomal Doxorubicin) | Approved (1995) | Ovarian Cancer/Kaposi’s Sarcoma | PFS 3–5 months gain; cardiotoxicity < 5% (vs. 20% free); 10–15% tumor accumulation | N/A | Ortho Biotech |
| Abraxane® (Albumin-Bound Paclitaxel) | Approved | Pancreatic/Breast Cancer | OS 8.5 vs. 6.7 months; neuropathy 3% (vs. 10%); AUC 2.5-fold increase | N/A | Celgene |
| MM-302 (HER2-Targeted Liposomal Doxorubicin) | II (Completed) | Breast Cancer | ORR 11% (vs. 0%); PFS 7.6 vs. 3.5 months | NCT02213744 | Merrimack Pharmaceuticals |
| ThermoDox® (Thermosensitive Liposomal Doxorubicin) | III (Ongoing) | Hepatocellular Carcinoma | CR 33% (vs. 12%) with RFA; 5-fold intratumoral DOX | NCT02112656 | Celsion Corporation |
| NK105 (Micellar Paclitaxel) | III (Recruiting) | Gastric Cancer | HR 0.7–0.8 for OS; response rates 20–50% higher | NCT02213744 | Nippon Kayaku |
| CALAA-01 (siRNA Nanoparticles) | I (Completed) | Solid Tumors/Melanoma | 21% tumor reduction at 0.6 mg/kg; RRM2 silencing | NCT00689065 | Calando Pharmaceuticals |
| mRNA-4157 (Lipid Nanoparticles) | II (Ongoing) | Melanoma | CD8+ response 70%; ORR 25% with pembrolizumab | NCT03897881 | ModernaTX |
| Vyxeos/CPX-351 (Liposomal Cytarabine/Daunorubicin) | Approved | Acute Myeloid Leukemia | Synergistic ratio 5:1; improved efficacy in AML-MRC | N/A | Jazz Pharmaceuticals |
| Onivyde® (Liposomal Irinotecan) | Approved | Pancreatic Cancer | OS 6.1 vs. 4.2 months; neutropenia 39% (vs. 24%) | N/A | Ipsen |
| Marqibo® (Liposomal Vincristine) | Approved | Acute Lymphoblastic Leukemia | Response rate 20%; neuropathy reduced by 50% | N/A | Talon Therapeutics |
| DepoCyt® (Liposomal Cytarabine) | Approved | Lymphomatous Meningitis | Response rate 41%; survival 99 days vs. 63 days | N/A | Sigma-Tau Pharmaceuticals |
| BIND-014 (Polymeric NP Docetaxel) | II (Completed) | Prostate Cancer | PSA reduction 40%; PFS 9.9 months | NCT01812746 | BIND Therapeutics |
| NK012 (Micellar SN-38) | II (Completed) | Small Cell Lung Cancer | ORR 18%; PFS 3.7 months | NCT00951613 | Nippon Kayaku |
| CRLX101 (Polymeric Camptothecin) | II (Completed) | Ovarian Cancer | PFS 3.7 months; stable disease 44% | NCT01652079 | Cerulean Pharma |
| Livatag® (Doxorubicin Transdrug) | III (Completed) | Hepatocellular Carcinoma | OS 15 months vs. 9.5 months; response rate 19% | NCT01655693 | Onxeo |
PFS: progression-free survival; OS: overall survival; HER2: human epidermal growth factor receptor 2; ORR: objective response rate; CR: complete response; RFA: radiofrequency ablation; AUC: area under the curve; DOX: doxorubicin; AML-MRC: acute myeloid leukemia with myelodysplasia-related changes; RRM2: ribonucleotide reductase regulatory subunit M2.