Table 2. Reported clinical activity of GITR agonists being evaluated in ongoing or completed clinical trials.
Agent (Sponsor) | Tumor type | Combination | Phase | Status | NCT.GOV ID | Single-agent activity | Combination activity | Primary publication |
---|---|---|---|---|---|---|---|---|
Monospecific agonistic antibody | ||||||||
AMG-228 (Amgen) | All solid tumors | Not observed | I/II | Completed | NCT02437916 | Not reported | Not applicable | Tran et al. [50] |
ASP1951 (Astellas) | All solid tumors | Pembrolizumab | I/II | Active, not recruiting | NCT03799003 | Not reported | Not reported | Not reported |
BMS-986156 (Bristol-Myers Squibb) | All solid tumors | Nivolumab | I/II | Completed | NCT02598960 | Not reported | Reported | Heinhuis et al. [47] |
Metastatic tumors in the liver or lung | Ipilimumab/nivolumab +/− SBRT | I/II | Active, not recruiting | NCT04021043 | Not reported | Not reported | Not reported | |
GWN323 (Novartis) | All solid tumors and lymphomas | Spartalizumab | I/II | Completed | NCT02740270 | Not reported | Reported | Piha-Paul et al. [49] |
INCAGN1876 (Incyte) | All solid tumors | N/A | I/II | Completed | NCT02697591 | Not reported | Not reported | Not reported |
All solid tumors | Ipilimumab or nivolumab | I/II | Completed | NCT03126110 | Not reported | Not reported | Not reported | |
Recurrent glioblastoma | Retifanlimab | II | Active, not recruiting | NCT04225039 | Not reported | Not reported | Not reported | |
MK-1248 (Merck) | All solid tumors | Not observed | I/II | Completed | NCT02553499 | Not reported | Reported | Geva et al. [46] |
MK-4166 (Merck) | All solid tumors | Pembrolizumab | I | Completed | NCT02132754 | Not reported | Reported | Papadopoulos et al. [48] |
REGN6569 (Regeneron) | All solid tumors | Cemiplimab | I | Active, recruiting | NCT04465487 | Not reported | Not reported | Not reported |
TRX518 (Leap Therapeutics) | All solid tumors | Anti-PD-1 nivolumab, pembrolizumab and chemotherapy | I/II | Completed | NCT02628574 | Reported | Reported | Davar et al. [45] |
Co-stimulatory GITR ligand | ||||||||
MEDI1873 (AstraZeneca) | All solid tumors | Not studied | I | Completed | NCT02583165 | No objective responses (prolonged stable disease) | N/A | Balmanoukian et al. [44] |