Table 1 Summary of selected novel agents that are under evaluation in currently actively recruiting clinical trials
Primary modes of action | Study agent(s) | NCT identifier | Phase | Disease stage |
|---|---|---|---|---|
MEK inhibitor + Bcl-2 inhibitor | Trametinib, navitoclax | NCT02079740 | Ib/II | LA, metastatic |
MEK inhibitor + ErbB inhibitor | PD-0325901, dacomitinib | NCT02039336 | I/II | Metastatic |
| Â | Trametinib, lapatinib | NCT02230553 | I/II | Metastatic |
EGFR TKI | Afatinib | NCT01728818 | II | Metastatic |
PI3K inhibitor | BKM120 | NCT01571024 | I | Metastatic |
| Â | BYL719 | NCT02155088 | I | LA, metastatic |
PI3K inhibitor + MEK inhibitor | BYL719, MEK162 | NCT01449058 | Ib/II | Metastatic |
AKT inhibitor | MK2206 | NCT01783171 | I | LA, metastatic |
PTEN inducer | AXP107-11 | NCT01182246 | Ib/II | LA, metastatic |
Wnt signaling inhibitor | OMP-54Â F28 | NCT02050178 | Ib | Metastatic |
| Â | OMP-18R5 | NCT02005315 | Ib | Metastatic |
| Â | PRI-724 | NCT01764477 | I | LA, metastatic |
| Â | LGK974 | NCT01351103 | I | LA, metastatic |
Glycogen synthase kinase-3 inhibitor | LY2090314 | NCT01632306 | I, II | Metastatic |
Notch signaling inhibitor | MK0752 | NCT01098344 | I | LA, metastatic |
| Â | PF-03084014 | NCT02109445 | Ib/II | Metastatic |
| Â | OMP-59R5 | NCT01647828 | Ib/II | Metastatic |
| Â | OMP-21Â M18 | NCT01189929 | Ib | LA, metastatic |
Anti-connective tissue growth factor mAb | FG-3019 | NCT02210559 | II | LA unresectable |
Heparan sulfate mimetic | M402 | NCT01621243 | I/II | Metastatic |
Hyaluronidase | PEGPH20 | NCT01839487 | II | Metastatic |
| Â | Â | NCT01959139 | I/II | Metastatic |
Hyaluronidase + anti-EGFR mAb | PEGPH20, cetuximab | NCT02241187 | NP | Resectable |
Oncolytic adenovirus encoding hyaluronidase | VCN-01 | NCT02045589 | I | LA, metastatic |
Hedgehog inhibitor | IPI-926 | NCT01383538 | I | LA, metastatic |
| Â | GDC-0449 | NCT01088815 | II | Metastatic |
| Â | LDE-225 | NCT01431794 | I/II | LA |
Hypoxia targeting agent | TH-302 | NCT02047500 | I | LA, metastatic |
TGF-β receptor I inhibitor | LY2157299 | NCT01373164 | Ib/II | LA, metastatic |
Hypomethylating agent | Azacitidine | NCT01845805 | II | Resected |
AMP-activated protein kinase (AMPK) activator | Metformin | NCT01954732 | I | Localized |
| Â | Metformin | NCT02005419 | II | Localized |
| Â | Metformin | NCT01666730 | II | Metastatic |
AMPK activator + mTOR inhibitor | Metformin, Rapamycin | NCT02048384 | Ib/II | Metastatic |
poly (ADP-ribose) polymerase (PARP) inhibitor | Veliparib | NCT01908478 | I | LA |
| Â | Veliparib | NCT01489865 | I/II | Metastatic |
| Â | Veliparib | NCT01585805 | II | LA, metastatic |
| Â | Rucaparib (AG-14699) | NCT02042378 | II | LA, metastatic (BRCA mutant) |
| Â | Olaparib (AZD2281) | NCT02184195 | III | Metastatic (BRCA mutant) |
Vascular targeting agent | ADH-1 | NCT01825603 | I | LA, metastatic |
Antiangiogenic combination | Tl-118 | NCT01509911 | II | Metastatic |
Arginine degrading enzyme | ADI-PEG 20 | NCT02101580 | Ib | LA, metastatic |
Aurora A kinase inhibitor | Alisertib (MLN8237) | NCT01924260, NCT01677559 | I | LA, metastatic |
CDK inhibitor + AKT inhibitor | Dinaciclib, MK2206 | NCT01783171 | I | LA, metastatic |
α-ketoglutarate dehydrogenase (KGDH) inhibitor | CPI-613 | NCT01835041 | I | Metastatic |
| Â | CPI-613 | NCT01839981 | I | LA, metastatic |
c-Met inhibitor | Cabozantinib (XL184) | NCT01663272 | I | LA, metastatic |
CRM-1 inhibitor | Selinexor (KPT-330) | NCT02178436 | Ib/II | Metastatic |
DNA minor groove binder | Lurbinectedin | NCT02210364 | I | LA unresectable |
Src inhibitor | Dasatinib | NCT01652976 | II | Metastatic |
Trk A, B, C inhibitors | PLX7486 | NCT01804530 | I | LA, metastatic |
IDO inhibitor | Indoximod | NCT02077881 | I/II | Metastatic |
| Â | NLG919 | NCT02048709 | I | Refractory |
Chemokine receptor 2 (CCR2) antagonist | PF-04136309 | NCT01413022 | I | LA |
Anti-tissue factor mAb | MORAb-066 | NCT01761240 | I | LA, metastatic |
Wee 1 inhibitor | MK1775 | NCT02037230 | I/II | LA unresectable |
BET bromodomain inhibitor | OTX015 | NCT02259114 | Ib | LA, metastatic |
SMAC mimetic | LCL161 | NCT01934634 | I | Metastatic |
Cancer stemness inhibitor | BBI608 | NCT02231723 | Ib | Metastatic |
Janus Kinase (JAK) inhibitor | Ruxolitinib | NCT01822756 | I | Metastatic |
| Â | Ruxolitinib | NCT02117479, NCT02119663 | III | Metastatic |
| Â | INCB039110 | NCT01858883 | Ib | Metastatic |
| Â | Momelotinib | NCT02101021 | II | Metastatic |
Autophagy inhibitor | Hydroxychloroquine | NCT01506973 | I/II | Metastatic |
| Â | Hydroxychloroquine | NCT01978184 | II | Resectable |
| Â | Hydroxychloroquine | NCT01494155 | II | Resectable |
Cancer vaccine | GVAX | NCT01088789 | II | Localized |
| Â | Poly ICLC and dendritic cells | NCT01677962 | 0 | LA unresectable |
| Â | Autologous tumor-derived HSP gp96 | NCT02133079 | I/II | Resected |
| Â | GVAX/CRS-207 | NCT02004262 | II | Metastatic |
| Â | Algenpantucel-L | NCT01836432 | III | LA |
hTERT DNA cancer vaccine | INO-1400 | NCT02327468 | I | Non-metastatic |
CTLA-4 inhibitor | Ipilimumab | NCT01473940 | Ib | LA, metastatic |
Anti-PD-1 mAb | CT-011 | NCT01313416 | II | Resected |
Vaccine + CTLA-4 inhibitor | GVAX, ipilimumab | NCT01896869 | II | Metastatic |
Vaccine + anti-PD-1 mAb | GVAX/CRS-207, nivolumab | NCT02243371 | II | Metastatic |
CTLA-4 inhibitor + anti-PD-1 mAb | Ipilimumab, nivolumab | NCT01928394 | I/II | LA, metastatic |
Anti-CPAA mAb | NPC-1C | NCT01834235 | I/II | LA, metastatic |
| Â | NPC-1C | NCT01040000 | II | LA, metastatic |
Anti-MUC1 mAb | BTH1704 | NCT02132403 | I | LA, metastatic |
Anti-CEA BiTE mAb | MEDI-565 | NCT01284231 | I | Refractory |
Anti-CA-125 mAb | Oregovomab | NCT01959672 | II | Non-metastatic |
Pegylated recombinant human IL-10 | AM0010 | NCT02009449 | I | Metastatic |
IL-1 receptor antagonist | Anakinra | NCT02021422 | I | Metastatic |
RAS specific immunotherapy | TG01 | NCT02261714 | I/II | Resected |
Radioimmunotherapy | 90Y-clivatuzumab tetraxetan (IMMU-107) | NCT01956812 | III | Metastatic |
Activated T-cells | EGFRBi armed ATC infusions | NCT01420874 | I | Metastatic |
Dendritic cell/cytokine-induced killer cells | DC-CIK | NCT01781520 | I/II | LA, metastatic |
siRNA-transfected PBMC | APN401 | NCT02166255 | I | LA, metastatic |
Autologous CAR T-cells | RNA mesothelin re-directed CAR T-cells | NCT01897415 | I | Metastatic |
| Â | Anti-mesothelin gene engineered lymphocytes | NCT01583686 | I/II | Metastatic |
Autologous natural killer T-cells | NKT cells | NCT01801852 | I | Refractory |
Activated dendritic cells | DCVax-Direct | NCT01882946 | I/II | LA, metastatic |
Autologous tumor infiltrating lymphocytes + interleukin | TIL, IL-2 | NCT01174121 | II | Metastatic |
Antiguanylyl cyclase C antibody-drug conjugate (ADC) | MLN0264 | NCT02202785 | II | LA, metastatic |
Micellar nanoparticle-encapsulated cisplatin | NC-6004 | NCT02043288 | III | LA or metastatic |
Alkylating agent | Glufosfamide | NCT01954992 | III | Metastatic |