District of Columbia
- Open-Label Study of single agent IMO-2055
- Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)
This is a study of 2 dose levels (0.16 or 0.64 mg/kg) of IMO-2055 administered by weekly
subcutaneous (SC) injections in two patient populations, treatment naïve or previously
treated patients. Each dose group (treatment naive or previously treated) will be
randomized to receive one of the 2 doses being studied.
- Histologically confirmed stage IV clear cell renal carcinoma with metastatic or
locally recurrent disease that is not surgically resectable.
- At least one measurable lesion
- Adequate organ function
- Any prior treatment of renal cell cancer was concluded at least 4 weeks prior.
- If female and of childbearing potential, a negative serum pregnancy test performed
and documented no more than 14 days before the first dose of study drug.
- Known untreated central nervous system (CNS) metastasis
- Pre-existing autoimmune or antibody-mediated diseases
- Other significant medical disease.