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 |