Table 1.
Completed clinical trials to evaluate TGF-β pathway antagonists.
| Target | Agent | Tumor type | Clinical efficacy | Starting date | Identifier |
|---|---|---|---|---|---|
| TGF-β2 | AP12009 Temozolomide PCV |
Glioblastoma Anaplastic Astrocytoma |
Not reported | 2007-02-06 | NCT00431561 |
| TGF-β2 | Lucanix | Non-small cell lung cancer | Mos:20 versus 17 m | 2008-05-13 | NCT00676507 |
| TGF-β2 | AP 12009 | Pancreatic Neoplasms Melanoma Colorectal Neoplasms |
Not reported | 2009-02-13 | NCT00844064 |
| CT RT TβRI |
LY2157299 Radiation Temozolomide |
Malignant Glioma | mOS:18.2 versus 17.9 m | 2010-10-13 | NCT01220271 |
| TβRI | LY2157299 Sorafenib Ramucirumab |
Hepatocellular Carcinoma | mPFS 2.7 m part A and 4.2 m part B | 2010-11-24 | NCT01246986 |
| TβRI | Galunisertib Gemcitabine Placebo |
Advanced or Metastatic Unresectable Pancreatic Cancer | mOS 8.9 versus 7.1 m | 2011-06-14 | NCT01373164 |
| TGF-β1 TGF-β2 TGF-β3 |
Fresolimumab RT |
Refractory breast cancer | ORR 0% | 2011-07-25 | NCT01401062 |
| TβRI | LY2157299 monohydrate Lomustine Placebo |
Glioblastoma | 2012-04-20 | NCT01582269 | |
| TβRII | LY3022859 | Advance solid tumors | Not reported | 2012-07-20 | NCT01646203 |
| TβRI | LY2157299 Gemcitabine |
Inoperable or metastatic pancreatic cancer | ORR 0% | 2014-06-03 | NCT02154646 |
| TβRI | TEW-7197 | Advanced Stage Solid Tumors | 2014-06-10 | NCT02160106 | |
| TβRI | LY2157299 Sorafenib |
Metastatic hepatocellular carcinoma | ORR 9% | 2014-09-15 | NCT02240433 |
| TGF-β RI | LY2157299 Lomustine |
Glioma | ORR 14% | 2012-09-10 | NCT01682187 |
| TGF-β RI | Galunisertib Durvalumab |
Metastatic Pancreatic Cancer | ORR 3% | 2016-04-12 | NCT02734160 |
| TGF-β RII PD-L1 |
M7824 | Human Papilloma VirusCervical Cancer Oropharyngeal CancerAnal Cancer Vaginal or Penile Cancer |
ORR 39% | 2018-02-09 | NCT03427411 |
| TGF-β RII PD-L1 |
M7824 | Advanced Adenocarcinoma of the Pancreas | Study was closed after one treatment related death. | 2018-03-02 | NCT03451773 |
| TGF-β RII PD-L1 |
MSB0011359C | Metastatic or Locally Advanced Solid Tumors | 2015-08-07 | NCT02517398 | |
| TGF-β RII/PD-L1 | M7824 | Pre-treated cervical tumors | ORR 28% | 2015-08-07 | NCT02517398 |
| TGF-β RII/PD-L1 | M7824 | Refractory head and neck cancer | ORR 22% | 2015-08-07 | NCT02517398 |
| TGF-β RII/PD-L1 | M7824 | Pre-treated NSCLC | PD-L1 > 1%, ORR 40%, PD-L1 > 80%,ORR 71% | 2015-08-07 | NCT02517398 |
| TGF-β RII PD-L1 |
M7824 | Pre-treated esophageal adenocarcinoma | ORR 20% | 2015-08-07 | NCT02517398 |
| TGF-β RII PD-L1 |
M7824 | Pre-treated gastric cancer | ORR 22% | 2015-08-07 | NCT02517398 |
| TGF-β RII PD-L1 |
M7824 | Pre-treated biliary tract cancer | ORR 23% | 2015-08-07 | NCT02517398 |
| TGF-β RII PD-L1 |
M7824 | Refractory colorectal cancer | ORR 3.4% | 2015-08-07 | NCT02517398 |
| Vaccine Anti-PD-1 |
Vigil Pembrolizumab |
Melanoma | 2015-10-14 | NCT02574533 |
The underlined NCT Number represents the National Clinical Trial number, which is an identification that ClinicalTrials.gov assigns a study when it is registered. The NCT number is assigned when the study is registered.