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Table 2 Ongoing clinical trials to evaluate TGF-β pathway antagonists in oncology

From: Novel therapies emerging in oncology to target the TGF-β pathway

Study NCT Registry Number Agent Target(s) Study Population Number of Patients Phase Clinical status
Small molecule receptor kinase inhibitors
NCT03724851 Vactosertib + Pembrolizumab TGF-β RI Metastatic CRC, gastric, or GEJC adenocarcinoma 67 Ib/IIa Active, recruiting
NCT03732274 Vactosertib + Durvalumab TGF-β RI PD-L1 Advanced NSCLC 63 Ib/IIa Active, recruiting
NCT04064190 Vactosertib + Durvalumab TGF-β RI PD-L1 Urothelial cancer 48 II Active, recruiting
NCT03143985 Vactosertib + Pomalidomide TGF-β RI IMiD Agent (Cereblon) Relapsed/ Refractory Multiple myeloma 18 Ib/IIa Active, recruiting
NCT03698825 Vactosertib + Paclitaxel TGF-β RI Tubulin/ Mitotic spindle Second line therapy for metastatic gastric AC 62 Ib/IIa Active, recruiting
NCT04103645 Vactosertib TGF-β RI Anemic, Ph-neg, MPN 37 II Active, not recruiting
NCT04258072 Vactosertib naI-IRI/FL TGF-β RI Chemotherapy Metastatic pancreatic Adenocarcinoma 24 Ib/IIa Active, not recruiting
NCT03802084 Vactosertib Imatinib TGF-β RI BCR-abl Advanced desmoid tumor 24 Ib/IIa Active recruiting
NCT02452008 Galunisertib + Enzalutamide TGF-β RI AR Castration-resistant prostate cancer 60 II Active, recruiting
NCT03206177 Galunisertib + Carboplatin/ Paclitaxel TGF-β RI Chemotherapy Ovarian carcinosarcoma 25 I Active, recruiting
NCT02688712  Galunisertib + Chemo/RT TGF-β RI Locally advanced rectal cancer   II Active, recruiting
NCT04031872 LY3200882 Capecitabine TGF-β RI Chemotherapy Advanced Chemotherapy Resistant Colorectal Cancer and an Activated TGF-beta Signature 31 I/II Active, not recruiting
Antibodies       
NCT02581787 Fresolimumab + SBRT TGF-β1, β2, β3 RT Stage Ia/Ib NSCLC 60 I/II Active, not recruiting
NCT03192345 SAR438459 + Cemiplimab TGF-β1, β2, β3 PD-L1 Advanced solid tumors 350 I Active, not recruiting
NCT04291079 SRK-181 + Anti-PD-L1 TGF-β1 PD-L1 Locally advanced or metastatic solid tumors 183 I First-in-human, dose-escalation, dose expansion study to evaluate safety, tolerability, PK, PD
Ligand Traps       
NCT04349280 Bintrafusp alfa TGF-β RII and PD-L1 Metastatic or Locally Advanced/Unresectable Urothelial Cancer With Disease Progression or Recurrence Following Treatment With a Platinum Agent 40 Ib Active, recruiting
NCT04501094 Bintrafusp alfa TGF-β RII and PD-L1 Checkpoint inhibitor naive urothelial carcinoma  75 II Active, not yet recruiting
NCT04066491 Cisplatin/Gemcitabine +/- Bintrafusp alfa Chemotherapy TGF-β RII and PD-L1 First-line Treatment of Biliary Tract Cancer 512 II/III Active, recruiting
NCT04220775 SBRT Bintrafusp alfa RT TGF-β RII and PD-L1 Recurrent or Second Primary Head and Neck Squamous Cell Cancer 21 I/II Active, not yet recruiting
NCT03833661 Bintrafusp alfa TGF-β RII and PD-L1  Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy 159 II Active, not recruiting
NCT03524170 Bintrafusp alfa TGF-β RII and PD-L1 Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer 20 I Active, recruiting
NCT04296942 Bintrafusp alfa TGF-β RII and PD-L1 Advanced Stage Breast Cancer (BrEAsT) 65 I Active, recruiting
  Brachyury-TRICOM Ado-trastuzumab Emtansine Vaccines HER2 HDAC deacetylase     
NCT03436563 Bintrafusp alfa TGF-β RII and PD-L1 Metastatic colorectal cancer or advanced solid tumors with MSI-high 74 I/II Active, recruiting
NCT03840915 Platinum regimen Bintrafusp alfa + and PD-L1 Chemotherapy TGF-β RII  Stage IV Non-small Cell Lung Cancer 70 Ib/II Active, not recruiting
NCT03840902 Chemo-RT Bintrafusp alfa +  Chemo-RT TGF-β RII  Unresectable Stage III Non-small Cell Lung Cancer. Bintrafusp alfa with concurrent chemoradiation followed by bintrafusp vs. concurrent chemoradiation + placebo followed by durvalumab 350 III Active, recruiting
Vaccines       
NCT02346747 Vigil Vaccine Stage IIIb, IIIc, IV high-grade papillary, serous, clear cell, serous ovarian cancer. 91 II Active, not recruiting
NCT03073525 Vigil Atezolizumab Vaccine PD-L1 Stage IIIb, IV ovarian cancer. Patients had tumor harvested at surgery and successful manufacturing of Vigil but were ineligible for CL-PTL-119 (the VITAL study) or previously randomized to placebo. 25 II Active, not recruiting
NCT02725489 Vigil Durvalumab Vaccine PD-L1 Advanced Women’s cancers. Confirmed diagnosis of women's cancer, inclusive, but not limited to breast, ovarian, fallopian tube, primary peritoneal, uterine, cervical, endometrial, that is locally advanced or metastatic for which the projected response rate to durvalumab is 15% or less. 13 II Active, not recruiting
NCT02511132 Vigil Vaccine  Metastatic Ewing's sarcoma refractory or intolerant to at least 1 prior line of systemic chemotherapy. 22 IIb Active, not recruiting
  vs. Gem/docetaxel Chemotherapy     (Part A)
   + Temozolomide/ Irinotecan     II (Part B)
NCT03842865 Vigil Vaccine  Expanded Access Trial of Vigil (Bi-shRNAfurin and GMCSF Augmented Autologous Tumor Cell Immunotherapy) in Advanced Solid Tumors including Ewing's sarcoma, Ewing's tumor metastatic, Ewing's sarcoma metastatic, advanced gynecological cancers, ovarian, cervical, and uterine cancers.  40 Expanded Access Temporarily not available
  1. Summary of ongoing clinical trials that are utilizing TGF-β targeting agents in solid tumor as well as hematological malignancies including MM and MPNs. Twelve trials utilized small molecule inhibitors, three utilized antibodies, nine utilized ligand traps, and five utilized vaccination strategies