Journal of Cancer Prevention

eISSN 2288-3657
pISSN 2288-3649

Currently ongoing clinical trials of TGF-β signaling pathway inhibitors for cancer treatment

Drug name Target type Treatment NCT number
Trabedersen (AP 12009) TGF-β2AS-ODN Advanced pancreatic, colorectal cancer, melanoma (phase I) NCT00844064(completed)
Fresolimumab (GC1008) TGF-β1 mAb NSCLC (phase I/II) NCT02581787
AVID200 TGF-β1/3 trap Malignant solid tumor (phase I) NCT03834662
ABBV-151 GARP/TGF-β1 mAb Advanced or metastatic solid tumor (phase I) NCT03821935
SRK-181 TGF-β1mAb Advanced solid tumor (phase I); alone or in combination with anti-PD-L1 NCT04291079
Bintrafusp alfa (M7824) TGF-β trap Advanced NSCLC (phase III) NCT03631706
Biliary tract cancer (phase II/III) NCT04066491
Thymoma and thymic carcinoma (phase II) NCT04417660
Urothelial carcinoma (phase II) NCT04501094
HPV associated cancers (phase II) NCT03427411
Cervical cancer (phase II) NCT04246489
Triple-negative breast cancer (phase II) NCT04489940
Esophageal squamous cell carcinoma (phase II) NCT04595149
Advanced biliary tract cancer (phase II) NCT03833661
Head and neck squamous cell carcinoma (phase II) NCT04428047
Cervical cancer (phase II) NCT04246489
Advanced colorectal cancers (phase II) NCT04491955
Metastatic colorectal cancer (phase I/II) NCT03436563
Advanced Kaposi sarcoma (phase I/II) NCT04303117
Advanced pancreatic cancer (phase I/II) NCT04327986
Galunisertib (LY2157299) TGF-β RI kinase inhibitor Metastatic prostate cancer (phase II) NCT02452008
Advanced hepatocellular carcinoma (phase II) NCT02178358
Recurrent glioblastoma (phase II) NCT01582269
Advanced hepatocellular carcinoma (phase I) NCT02906397
Triple-negative breast cancer (phase I) NCT02672475
Carcinosarcoma of uterus or ovary (phase I); in combination with Paclitaxel/Carboplatin NCT03206177
Rectal adenocarcinoma (phase I) NCT02688712
Recurrent malignant glioma (phase I) NCT01682187
Vactosertib (TEW-7197) TGF-β RI kinase inhibitor Myeloproliferative neoplasms (phase II) NCT04103645
Metastatic colorectal or gastric cancer (phase I/II); in combination with Pembrolizumab NCT03724851
Advanced NSCLC (phase I/II); in combination with Durvalumab NCT03732274
Metastatic gastric cancer (phase I/II); in combination with Paclitaxel NCT03698825
Myelodysplastic syndrome (phase I/II) NCT03074006
Refractory multiple myeloma (phase I); in combination with Pomalidomide NCT03143985
Advanced desmoid tumor (phase I); in combination with Imatinib NCT03802084
Urothelial carcinoma (phase I); in combination with Durvalumab NCT04064190(not yet recruiting)
PD-L1 positive NSCLC (phase II); in combination with Pembrolizumab NCT04515979(not yet recruiting)
Pancreatic ductal adenocarcinoma (phase I);in combination with nal-IRI+5FU/LV NCT04258072(not yet recruiting)

AS-ODN, antisense oligonucleotides; NCT, National Clinical Trial; NSCLC, non-small cell lung cancer; mAb, monoclonal antibody; GARP, glycoprotein A repetitions predominant; anti-PD-L1, anti-programmed death-ligand 1; HPV, human papillomavirus; TGF-β-RI, TGF-β receptor type I; nal-IRI+5FU/LV, nanoliposomal irinotecan plus 5-fluorouracil/leucovorin. Data from (

J Cancer Prev 2020;25:213~222
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