A Study of Intratumoral IMO-2125 in Patients With Refractory Solid Tumors

Inclusion Criteria:

• Patients must have histologically or cytologically confirmed diagnosis of cancer not amenable to curative therapy.
• Patients who have a diagnosis for which a PD(L)-1 inhibitor is FDA approved must have previously received treatment with one of these therapies.
• Patients must have a disease that is measurable by RECIST v1.1 and at least 2 tumors that are accessible to biopsy.
• Patients must be 18 years of age or older.
• Patients must have ECOG Performance Status ≤2.

• Patients must meet the following laboratory criteria:

  1. ANC ≥1.5 x 109/L (≥1500/mm3)
  2. Platelet count ≥100 x 109/L (≥100,000/mm3)
  3. Hemoglobin ≥8.0 g/dL (≥4.96 mmol/L)
  4. Serum creatinine ≤1.5 x ULN or 24-hour creatinine clearance ≥60 mL/minute
  5. AST ≤2.5 x ULN; ALT ≤2.5 x ULN or AST/ALT <5 x ULN if liver involvement
  6. Serum bilirubin ≤1.5 x ULN, except in patients with Gilbert's Syndrome who must have a total bilirubin <3 mg/dL (51.3 μmol/L)

Exclusion Criteria:

• Patients who have received prior therapy with a TLR agonist (prior treatment with a topical TLR agonist (e.g. imiquimod) is permitted).
• Patients who have received treatment with IFN-α within the previous 6 months prior to enrollment.
• Patients with known hypersensitivity to any oligodeoxynucleotide that cannot be adequately managed with appropriate prophylaxis.
• Patients with active autoimmune disease requiring disease-modifying therapy.
• Patients requiring concurrent systemic steroid therapy higher than physiologic dosage (7.5 mg/day of prednisone or equivalent).
• Patients with another primary malignancy that has not been in remission for at least 3 years. The following are exempt from the 3-year limit: non-melanoma skin cancer, curatively treated localized prostate cancer with non-detectable prostate-specific antigen, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Papanicolaou (Pap) smear, and thyroid cancer (except anaplastic).
• Patients with active infections requiring systemic treatment.
• Patients who are known to be hepatitis B surface antigen positive.
• Patients with a known diagnosis of human immunodeficiency virus (HIV) infection.
• Women who are pregnant or breastfeeding.
• Patients with known central nervous system, meningeal, or epidural disease. Patients with stable brain metastases following definitive local treatment are eligible if steroid requirement is <7.5 mg/day of prednisone (or equivalent).
• Patients with impaired cardiac function or clinically significant cardiac disease.