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 |