Table 2.
Clinical Trials of TLR9 Agonists as Monotherapy
| TLR9 Agonist | Study Phase | Histology | ROA | Safety | Efficacy |
|---|---|---|---|---|---|
| PF-3512676 (CPG 7909)163 | Phase I | Advanced BCC or melanoma | SC 0.01 to 2.5 mg, every 2 weeks | 1 grade 3 event | ORR (BCC): 1 CR (1/5, 20%), 4 PR (80%) ORR (melanoma): 1 CR (1/5, 20%) |
| PF-3512676 (CPG 7909)164 | Phase I | CTCL | SC 0.08–0.36mg/kg, weekly | 9/28 (32%) grade ≥3 events | 32% per CAILS |
| PF-3512676 (CPG 7909)165 | Phase I | Advanced RCC | SC 0.08–0.81mg/kg, weekly | 6/40 (15%) grade ≥3 events | ORR: 5% (2/39) |
| MGN1703166 | Phase I | All solid tumors, testing | SC 0.25–60mg, twice weekly | 2 grade 3 events | ORR: 0% 25% (6/24) SD |
| CMP-001167 | Phase I | Advanced metastatic melanoma | IT 5–10mg weekly for 7 weeks, then q3 weekly | Not reported | ORR 22% (5/23) |
| PF-3512676 (CPG 7909)168 | Phase II | Advanced metastatic melanoma | SC 0.08–0.81mg/kg, weekly | 5/20 (20%) grade ≥3 events | ORR: 10% (2/20) SD rate: 15% (3/20) |
Abbreviations: BCC, basal cell carcinoma; CAILS, Composite Assessment of Index Lesion Severity; CTCL, cutaneous T cell lymphoma; CR, complete response; ORR, overall response rate; PR, partial response; ROA, route of administration; RCC, renal cell carcinoma; SD, stable disease.