TABLE 3.
Overview of anti-TGF-β therapies based on the interference between ligand-receptor interactions used in cancer clinical trials.
| Drug (target) | Clinical trial (phase) | Status | Cancer type | Patients enrolled | Arms | Outcomes |
| GC1008 (TGF-β1 and TGF-β2) | NCT00923169 (Phase I) | Completed | Renal cell carcinoma and melanoma | 22 | GC1008 (10 mg/kg) GC1008 (15 mg/kg) |
Highest safe dose: 15 mg/kg |
| GC1008 (TGF-β1 and TGF-β2) | NCT01472731 (Phase II) | Completed | Glioma | 12 | Bioimaging with 89Zr-GC1008 (37 MBq total) Treatment with GC1008 (5 mg/kg) |
NA |
| GC1008 (TGF-β1 and TGF-β2) | NCT01112293 (Phase II) | Completed | Mesothelioma | 14 | Single-arm:GC1008 (3 cycles) | NA |
| GC1008 (TGF-β1 and TGF-β2) | NCT01401062 (Phase II) | Completed | Metastatic breast cancer | 23 | GC1008 (1 mg/kg) + radiotherapy GC1008 (10 mg/kg) + radiotherapy |
No improvement in abscopal effect Improved OS in arm II |
| NIS793 (TGF-β) | NCT02947165 (Phase I) | Recruiting | Breast, lung, hepatocellular, colorectal, pancreatic and renal cancers | 220 | NIS793 NIS793 + PDR001 |
NA |
| SAR439459 (TGF-β1, TGF-β2 and TGF-β3) | NCT03192345 (Phase I) | Recruiting | Advanced solid tumors | 225 | SAR439459 (dose escalation) SAR439459 (dose expansion) SAR439459 (dose escalation) + cemiplimab SAR439459 (dose expansion) + cemiplimab |
NA |
| LY3022859 (TβRII) | NCT01646203 (Phase I) | Completed | Advanced solid tumors | 14 | IMC-TR1 (1.25 mg/kg) IMC-TR1 (dose escalation – 12.5 to 1600 mg) IMC-TR1 (dose escalation – 800 to 1600 mg) |
DLT reported TEAE reported SAE reported |
| AVID200 (TGF-β1 and TGF-β3) | NCT03834662 (Phase I) | Recruiting | Malignant solid tumors | 36 | AVID200 (180 mg/m2) AVID200 (550 mg/m2) AVID200 (1100 mg/m2) |
NA |
OS, overall survival; DLT, dose-limiting toxicity; TEAE, treatment emergent adverse events; SAE, serious adverse event; NA, not available.