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Table 1 Therapies targeting TGF-β signaling under clinical trials in the past 3 years

From: Targeting TGF-β signal transduction for fibrosis and cancer therapy

Drug Mechanism Indication Development stage ClinicalTrials.gov identifier
SAR439459 Pan- TGFβ neutralizing antibody Advanced Malignant Solid Neoplasm/Metastatic Malignant Solid Neoplasm/Unresectable Malignant Solid Neoplasm Phase 1 NCT04729725
Plasma Cell Myeloma Refractory Phase1/Phase 2 NCT04643002
Advanced Liver Cancers Phase1/Phase 2 NCT04524871
NIS793 Fully human anti-TGF-β IgG2 monoclonal antibody Metastatic Pancreatic Ductal Adenocarcinoma Phase2/Phase 3 NCT04390763/NCT04935359
Myelofibrosis Phase1/Phase 2 NCT04097821
Myelodysplastic Syndromes Phase 1 NCT04810611
ABBV151 Humanized monoclonal antibody inhibitor of GARP- TGF-β1 Advanced Solid Tumors Cancer Phase 1 NCT03821935
AVID200 Engineered TGF-β ligand trap Malignant Solid Tumor Phase 1 NCT03834662
Primary Myelofibrosis/Post-essential Thrombocythemia Myelofibrosis/Post-polycythemia Vera Myelofibrosis Phase 1 NCT03895112
Scleroderma, Diffuse Phase 1 NCT03831438
M7824 (bintrafusp alfa) Bifunctional anti-PD-L1/TGF-βRII Trap fusion protein Thymic Epithelial Tumor/Recurrent Thymoma/Thymic Cancer Phase 2 NCT04417660
Metastatic Colorectal Cancer/Advanced Solid Tumors With Microsatellite Instability Phase1/Phase 2 NCT03436563
HPV Positive Cancer Phase1/Phase 2 NCT04432597
Urothelial Cancer Phase 2 NCT04501094
Kaposi Sarcoma Phase1/Phase 2 NCT04303117
Urothelial Cancer/Bladder Cancer/Genitourinary Cancer/Urogenital Neoplasms/Urogenital Cancer Phase 1 NCT04235777
Advanced Pancreas Cancer Phase1/Phase 2 NCT04327986
Mesothelioma; Lung Phase 2 NCT05005429
Stage II-III HER2 Positive Breast Cancer Phase 1 NCT03620201
Relapsed Small Cell Lung Cancers Phase1/Phase 2 NCT03554473
Unresectable Stage III Non-Small-Cell Lung Cancer Phase 2 NCT03840902
Advanced Stage Breast Cancer Phase 1 NCT04296942
Prostate Neoplasms Phase1/Phase 2 NCT04633252
Metastatic Triple-Negative Breast Cancer Phase 1 NCT03579472
Advanced Solid Tumors Phase1/Phase 2 NCT04574583
Metastatic Prostate Cancer/Advanced Solid Tumors Phase1/Phase 2 NCT03493945
Advanced HPV Associated Malignancies Phase1/Phase 2 NCT04287868
Metastatic Checkpoint Refractory HPV Associated Malignancies/Microsatellite Stable Colon Cancer (MSS) Phase 1/Phase 2 NCT04708470
Triple-Negative Breast Neoplasms Phase 2 NCT04489940
Small Bowel Cancers/Colorectal Cancers Phase 2 NCT04491955
Esophageal Squamous Cell Carcinoma Phase 2 NCT04595149
Untreated Resectable Non-Small-Cell Lung Cancer Phase 2 NCT04560686
Cancers With Brain Metastases Phase1/Phase 2 NCT04789668
Recurrent Head and Neck Squamous Cell Carcinoma/Second Primary Squamous Cell Carcinoma of the Head and Neck Phase1/Phase 2 NCT04220775
Metastatic or Locally Advanced Urothelial Cancer Phase 1 NCT04349280
Squamous Cell Carcinoma of Head and Neck Phase 2 NCT04428047
Biliary Tract Cancer/Cholangiocarcinoma Phase 2 NCT04727541
Advanced Non-small-Cell Lung Cancer Phase 2 NCT04396535
Locally Advanced or Metastatic Tyrosine Kinase Inhibitor-Resistant EGFR-Mutant Non-small-Cell Lung Cancer Phase 2 NCT04971187
GFH018 Inhibitor of TGF-βRI Advanced Solid Tumor Phase1/Phase 2 NCT04914286
SHR-1701 Bifunctional anti-PD-L1/TGF-βRII agent Pancreatic Cancer Phase1/Phase 2 NCT04624217
Metastatic or Locally Advanced Solid Tumors Phase 1 NCT03710265/NCT03774979
Advanced Solid Tumors Phase1/Phase 2 NCT04856774
Nasopharyngeal Carcinoma Phase 1 NCT04282070
Advanced Solid Tumors Phase 1 NCT04324814
Metastatic Colorectal Cancer Phase2/Phase 3 NCT04856787
Advanced Solid Tumors and B-cell Lymphomas Phase1/Phase 2 NCT04407741
JS201 Recombinant PD-1 monoclonal antibody/TGF-βRII bifunctional fusion protein Advanced Malignant Tumors Phase 1 NCT04956926
Small-cell Lung Cancer Phase 2 NCT04951947
TST005 Bispecific antibody consisting of a PD-L1 monoclonal antibody (mAb) and a TGF-β trap Locally Advanced or Metastatic Cancers/Metastatic Human Papillomavirus-Related Malignant Neoplasm Phase 1 NCT04958434
TASO-001 Antisense oligonucleotide against TGF-β2 Advanced or Metastatic Solid Tumor Phase 1 NCT04862767
TEW-7197 (Vactosertib) TGF-β receptor ALK4/ALK5 inhibitor Metastatic Pancreatic Cancer Phase1/Phase 2 NCT03666832
Advanced Stage Solid Tumors Phase 1 NCT02160106
Myeloproliferative Neoplasm Phase 2 NCT04103645
LY2157299 (galunisertib) Small molecule antagonist of the tyrosine kinase TGFBR1 Nasopharyngeal Carcinoma Phase 2 NCT04605562
LY3200882 Inhibitor of TGFβRI Solid Tumor Phase 1 NCT02937272
TRK250 siRNA-based oligonucleotide selectively suppressing TGFβ1 Idiopathic Pulmonary Fibrosis Phase 1 NCT03727802
STP705 siRNA-based oligonucleotide selectively suppressing TGFβ1 and COX-2 Basal Cell Carcinoma Phase 2 NCT04669808
Bowen's Disease/Cutaneous Squamous Cell Carcinoma in Situ Phase1/Phase 2 NCT04293679
Keloid Phase 2 NCT04844840
Hepatocellular Carcinoma/Liver Metastases/Cholangiocarcinoma Phase 1 NCT04676633
Squamous Cell Carcinoma in Situ Phase 2 NCT04844983
QLS31901 PDL1/TGFβ antibody Advanced Malignant Tumor Phase 1 NCT04954456
ACE-1334 superfamily based ligand trap of TGFβ1 and c3 Systemic Sclerosis With and Without Interstitial Lung Disease Phase 1/Phase 2 NCT04948554
ACE-536 (Luspatercept) TGFβ superfamily ligand trap Myelodysplastic Syndromes Phase2/Phase 3 NCT04477850/NCT03900715/NCT03682536
Myelodysplastic Syndromes/Β-thalassemia/Myeloproliferative Neoplasm-Associated Myelofibrosis Phase 3 NCT04064060
Myeloproliferative Disorders/Myelofibrosis/Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/Anemia Phase 3 NCT04717414
Β-Thalassemia Phase 2 NCT04143724
Primary Myelofibrosis/Post-Polycythemia Vera/Myelofibrosis Phase 3 NCT03755518
NNC0361-0041 Recombinant supercoiled plasmid encoding PPI, TGF-β1, IL-10, and IL-2 Type I Diabetes Phase 1 NCT04279613
PF-06952229 TGFβ1 inhibitor Advanced Solid Tumors Phase 1 NCT03685591
GT90001 Fully human anti-ALK-1 mAb (IgG2) Metastatic Hepatocellular Carcinoma Phase1/Phase 2 NCT03893695
Solid Tumors Phase1/Phase 2 NCT04984668
Trabedersen TGFβ2 specific phosphorothioate antisense oligodeoxynucleotide COVID-19 Phase 2 NCT04801017