Table 2.
Clinical trials that evaluated TGF-β signaling pathways small molecule receptor kinase inhibitors, antisense nucleotides and vaccines in disease
| Agent | Targets | ClinicalTrials.gov Identifier | Indication | Number of Patients | Phase | Treatment | Status |
|---|---|---|---|---|---|---|---|
| Small molecule kinase inhibitors | |||||||
| Vactosertib (TEW-7197) | TGF-βRI | NCT05436990 | Melanoma | 30 | Phase II | +Pembrolizumab | Not yet recruiting |
| NCT03143985 | Multiple myeloma | 18 | Phase I | +Pomalidomide | Recruiting | ||
| NCT04064190 | UC | 48 | Phase II | +Durvalumab | Not yet recruiting | ||
| NCT04515979 | NSCLC | 55 | Phase II | +Pembrolizumab | Recruiting | ||
| NCT04103645 | Myeloproliferative neoplasms | 37 | Phase II | Monotherapy | Recruiting | ||
| NCT04893252 | Gastric cancer | 55 | Phase II | +Durvalumab | Not yet recruiting | ||
| NCT04258072 | Pancreatic cancer | 24 | Phase I | +Chemotherapy | Recruiting | ||
| NCT03802084 | Desmoid tumor | 24 | Phase I/II | +Imatinib | Recruiting | ||
| NCT03724851 | GC/GEJC | 67 | Phase I/II | +Pembrolizumab | Active, not recruiting | ||
| NCT04656002 | Gastric cancer | 43 | Phase II | +Paclitaxel+Ramucirumab | Not yet recruiting | ||
| NCT03732274 | NSCLC | 60 | Phase I/II | +Durvalumab | Active, not recruiting | ||
| NCT03844750 | Colorectal cancer | 19 | Phase II | +Pembrolizumab+Hepatectomy | Recruiting | ||
| NCT03698825 | Gastric cancer | 62 | Phase I/II | +Paclitaxel | Active, not recruiting | ||
| Galunisertib (LY2157299) | TGF-βRI | NCT02672475 | TNBC | 29 | Phase I | +Paclitaxel | Active, not recruiting |
| NCT02452008 | Prostate cancer | 60 | Phase II | +Enzalutamide | Recruiting | ||
| NCT03206177 | Carcinosarcoma | 26 | Phase I | +Paclitaxel/Carboplatin | Active, not recruiting | ||
| NCT02688712 | Colorectal cancer | 50 | Phase II | +Neoadjuvant Chemoradiation | Active, not recruiting | ||
| LY3200882 | TGF-βRI | NCT02937272 | Solid tumor | 223 | Phase I | Monotherapy | Active, not recruiting |
| GFH018 | TGF-βRI | NCT05051241 | Solid tumor | 60 | Phase I | Monotherapy | Recruiting |
| NCT04914286 | Solid tumor | 195 | Phase I/II | +Toripalimab | Recruiting | ||
| NCT05386888 | NSCLC | 65 | Phase II | +Toripalimab | Not yet recruiting | ||
| SHR-1701 | PD-L1/TGF-βRII | NCT05106023 | Melanoma | 31 | Phase II | +Temozolomide | Not yet recruiting |
| NCT05020925 | NPC | 30 | Phase I/II | +Famitinib | Not yet recruiting | ||
| NCT04650633 | HNSCC | 130 | Phase II | Monotherapy | Recruiting | ||
| NCT04624217 | Pancreatic cancer | 56 | Phase I/II | +Chemotherapy | Active, not recruiting | ||
| NCT03710265 | Solid tumor | 206 | Phase I | Monotherapy | Recruiting | ||
| NCT04937972 | NSCLC | 71 | Phase II | +Fluazopalil | Recruiting | ||
| NCT04974957 | NSCLC | 71 | Phase II | +BP102 | Not yet recruiting | ||
| NCT05300269 | Rectal cancer | 73 | Phase II | +Radiotherapy and Chemotherapy | Recruiting | ||
| NCT04884009 | SCLC | 106 | Phase II | Monotherapy/+Famitinib | Not yet recruiting | ||
| NCT04580498 | NSCLC | 122 | Phase II | Monotherapy/+Chemotherapy | Not yet recruiting | ||
| NCT05177497 | NSCLC | 19 | Phase II | Monotherapy | Not yet recruiting | ||
| NCT05149807 | GC/GEJC | 896 | Phase II | Monotherapy | Enrolling by invitation | ||
| NCT04856774 | Solid tumor | 113 | Phase I/II | +BP102 | Recruiting | ||
| NCT04282070 | NPC | 91 | Phase I | Monotherapy/+Chemotherapy | Active, not recruiting | ||
| NCT04679038 | Solid tumor | 222 | Phase I/II | Monotherapy/+Famitinib | Recruiting | ||
| NCT04856787 | Colorectal cancer | 439 | Phase II | +BP102 and XELOX | Recruiting | ||
| NCT04324814 | Solid tumor | 48 | Phase I | Monotherapy | Active, not recruiting | ||
| NCT05179239 | Cervical cancer | 572 | Phase III | +Chemotherapy+BP102 | Recruiting | ||
| NCT04699968 | NSCLC | 168 | Phase II | Monotherapy/+Famitinib | Not yet recruiting | ||
| NCT05132413 | NSCLC | 561 | Phase III | +Bevacizumab and Chemotherapy | Not yet recruiting | ||
| NCT04950322 | GC/GEJC | 920 | Phase III | +Chemotherapy | Recruiting | ||
| NCT04407741 | Solid tumor and B-cell lymphomas | 100 | Phase I/II | Monotherapy/+SHR2554 | Recruiting | ||
| NCT04560244 | NSCLC | 15 | Phase II | Monotherapy | Not yet recruiting | ||
| Antisense nucleotides | |||||||
| STP705 | TGF-β1/COX-2 | NCT04669808 | Basal cell carcinoma | 15 | Phase II | Monotherapy | Recruiting |
| NCT05421013 | Bowen’s disease | 30 | Phase I/II | Monotherapy | Recruiting | ||
| NCT04844840 | Keloid recurrence | 60 | Phase II | Monotherapy | Recruiting | ||
| NCT05196373 | Hypertrophic scar | 50 | Phase I/II | Monotherapy | Not yet recruiting | ||
| NCT04676633 | HCC | 50 | Phase I | Monotherapy | Recruiting | ||
| NCT04844983 | Bowen’s disease | 100 | Phase II | Monotherapy | Recruiting | ||
| Vaccines | |||||||
| Vigil (Gemogenovatucel-T) | TGF-β1, β2 | NCT03495921 | Ewing’s sarcoma | 114 | Phase III | +Irinotecan and Temozolomide | Active, not recruiting |
| NCT03073525 | Gynecological cancers | 25 | Phase II | +Atezolizumab | Active, not recruiting | ||
| NCT01309230 | Ovarian cancer | 44 | Phase II | Monotherapy | Active, not recruiting | ||
| NCT02346747 | Ovarian cancer | 91 | Phase II | Monotherapy | Active, not recruiting | ||
UC Urothelial carcinoma, NSCLC Non-small cell lung cancer, GC/GEJC Gastric cancer/gastroesophageal junction cancer, TNBC Triple-negative breast cancer, NPC Nasopharyngeal carcinoma, HNSCC Head and neck squamous cell carcinoma, HCC Hepatocellular carcinoma