Table 3.
Table of clinical trials associated with technologies developed by Alliance investigators
| Cancer Indication | Trial Name | Year Started | Phase | Sponsor | Particle Type |
|---|---|---|---|---|---|
| Solid tumor | Study of CRLX101 (formerly named IT-101) in the treatment of advanced solid tumors (NCT00333502) | 2006 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Solid tumor | Safety study of CALAA-01 to treat solid tumor cancers (NCT00689065) | 2008 | 1 | Calando Pharmaceuticals | Polymeric nanoparticle |
| Metastatic melanoma | Study of gene modified immune cells in patients with advanced melanoma (NCT00910650) | 2009 | 2 | UCLA Jonsson Comprehensive Cancer Center | Diagnostic assay |
| Advanced solid tumors with liver involvement | Evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of intravenous ALN-VSP02 in patients with advanced solid tumors with liver involvement (NCT00882180) | 2009 | 1 | Alnylam Pharmaceuticals | Lipid nanoparticle |
| Advanced solid tumors with liver involvement | Extension study of ALN-VSP02 in cancer patients who have responded to ALN-VSP02 treatment (NCT01158079) | 2010 | 1 | Alnylam Pharmaceuticals | Lipid nanoparticle |
| Non-small cell lung cancer | A Phase 2 study of CRLX101 in patients with advanced non-small cell lung cancer (NCT01380769) | 2011 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Prostate cancer | Transrectal photoacoustic imaging of the prostate (NCT01380769) | 2011 | NA | Stanford University | Transrectal imaging device |
| Solid tumor, Metastatic cancer | A study of BIND-014 given to patients with advanced or metastatic cancer (NCT01300533) | 2011 | 1 | BIND Therapeutics | Targeted polymeric nanoparticle |
| Metastatic melanoma, Malignant brain tumors | PET imaging of patients with melanoma and malignant brain tumors using an 124I-labeled cRGDY silica nanomolecular particle tracer: A microdosing study (NCT01266096) | 2011 | NA | Memorial Sloan Kettering Cancer Center | Silica nanoparticle (C-dots) |
| Metastatic stomach, gastro-esophageal, or esophageal cancer | Pilot trial of CRLX101 in treatment of patient with advanced or metastatic stomach, gastroesophageal, or esophageal cancer that cannot be removed by surgery (NCT01612546) | 2012 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Renal cell carcinoma | CRLX101 plus bevacizumab in advanced RCC (NCT01625936) | 2012 | 1 | Cerulean Pharma | Polymer-drug conjugate |
| Ovarian cancer, fallopian tube cancer, and primary peritoneal cancer | CRLX101 in combination with bevacizumab for recurrent ovarian/tubal/peritoneal cancer (NCT01652079) | 2012 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Rectal cancer | Neoadjuvant chemoradiotherapy with CRLX-101 and capecitabine for rectal cancer (NCT02010567) | 2013 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Extensive stage or recurrent small cell lung cancer | Topotecan hydrochloride or cyclodextrin-based polymer-camptothecin CRLX101 in treating patients with recurrent small cell lung cancer (NCT01803269) | 2013 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Prostate cancer, Castration-resistant prostate cancer | A Phase 2 study to determine the safety and efficacy of BIND-014 (Docetaxel nanoparticles for injectable suspension) administered to patients with metastatic castration-resistant prostate cancer (NCT01812746) | 2013 | 2 | BIND Therapeutics | Targeted polymeric nanoparticle |
| Non-small cell lung cancer | A Phase 2 study to determine the safety and efficacy of BIND-014 (Docetaxel nanoparticles for injectable suspension) as second-line therapy to patients with non-small cell lung cancer (NCT01792479) | 2013 | 2 | BIND Therapeutics | Targeted polymeric nanoparticle |
| Breast neoplasms | Comparison of stationary breast tomosynthesis and 2-D digital mammography in patients with known breast lesions (NCT01773850) | 2013 | NA | UNC Lineberger Comprehensive Cancer Center | Carbon nanotubes |
| Metastatic renal cell carcinoma | CRLX101 in combination with bevacizumab for metastatic renal cell carcinoma (mRCC) versus standard of care (SOC) (NCT02187302) | 2014 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Squamous cell non-small cell lung cancer, KRAS-positive patients with non-small cell lung cancer | A study of BIND-014 (Docetaxel nanoparticles for injectable suspension) as second-line therapy for patients with KRAS-positive or squamous cell non-small cell lung cancer (NCT02283320) | 2014 | 2 | BIND Therapeutics | Targeted polymeric nanoparticles |
| Head and neck melanoma, breast cancer, and colorectal cancers | Targeted silica particles for real-time image-guided intraoperative mapping of nodal metastases (NCT02106598) | 2014 | 2b | Memorial Sloan Kettering Cancer Center | Silica nanoparticles (C-dots) |
| Solid tumors | Alternative dosing for CRLX101 alone, with Avastin and with mFOLFOX6 in advanced solid tumors (NCT02648711) | 2015 | 1 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Ovarian cancer | A Study of CRLX101 in combination with weekly Paclitaxel in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer (NCT02389985) | 2015 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Urothelial carcinoma cholangiocarcinoma, cervical cancer, squamous cell carcinoma of head and neck | A Study of BIND-014 in patients with urothelial carcinoma, cholangiocarcinoma, cervical cancer and squamous cell carcinoma of the head and neck (NCT02479178) | 2015 | 2 | BIND Therapeutics | Targeted polymeric nanoparticle |
| Advanced cancers | Eph2A gene targeting using neutral liposomal small interfering RNA delivery (NCT01591356) | 2015 | 1 | MD Anderson Cancer Center | DOPC nanoliposomes |
| Advanced solid tumor malignancy | Phase 1/2a dose-escalation study of CRLX301 in patients with advanced solid tumors (NCT02380677) | 2015 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Advanced solid tumors | A Phase 1 study of safety, tolerability, and PK of AZD2811 in patients with advanced solid tumors (NCT02579226) | 2015 | 1 | AstraZeneca | Targeted polymeric nanoparticle |
| Small cell lung carcinoma, non-small-cell lung carcinoma, lung neoplasms, small cell lung cancer, and lung cancer | Trial of CRLX101, a nanoparticle Camptothecin with Olaparib in people with relapsed/refractory small cell lung cancer (NCT02769962) | 2016 | 2 | NewLink Genetics (formerly Cerulean) | Polymer-drug conjugate |
| Gliosarcoma, Recurrent glioblastoma | NU-0129 in treating patients with recurrent glioblastoma or gliosarcoma undergoing surgery (NCT03020017) | 2017 | 1 | Northwestern University | Gold core spherical nucleic acid |
| Healthy volunteers | A study Of AST-008 in healthy subjects (NCT03086278) | 2017 | 1 | Exicure Inc | Gold core spherical nucleic acid |
| Advanced or metastatic: solid tumors, melanoma, head and neck squamous cell carcinoma, cutaneous squamous cell carcinoma, merkel cell carcinoma | Intratumoral AST-008 combined with Pembrolizumab in patients with advanced solid tumors (NCT03684785) | 2018 | 2 | Exicure Inc | Gold core spherical nucleic acid |
| Advanced Tumors | Phase 1 Study of RiMO-301 With Radiation in Advanced Tumors (NCT03444714) | 2018 | 1 | RiMO Therapeutics | Nano metal-organic framework (nMOF) |
| Malignant brain tumors | PET Imaging of Patients With Malignant Brain Tumors Using 89Zr-cRGDY Ultrasmall Silica Particle Tracers: A Phase 1 Microdosing Study (NCT03465618) | 2018 | 1 | Memorial Sloan Kettering Cancer Center | Silica nanoparticles (C-dots) |
| Advanced Tumors | Study of CPI-100 in Patients with Advanced Tumors (NCT03781362) | 2018 | 1 | Coordination Pharmaceuticals | Nanoscale coordination polymer |
| Advanced Tumors | Study of CPI-200 in Patients with Advanced Tumors (NCT03953742) | 2019 | 1 | Coordination Pharmaceuticals | Nanoscale coordination polymer |