Study of IMO-2055 in Metastatic or Locally Recurrent Clear Cell Renal Carcinoma

Idera Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Renal Cell Carcinoma

Treatments: Drug: IMO-2055

Study type: Interventional

Funder types: Industry

Identifiers

NCT00729053

2055-003

Details and patient eligibility

About

• Multi-Center
• Randomized
• Open-Label Study of single agent IMO-2055
• Patients who have Metastatic or Locally Recurrent Clear Cell Renal Carcinoma (RCC)

Full description

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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Known untreated central nervous system (CNS) metastasis
• Pre-existing autoimmune or antibody-mediated diseases
• Other significant medical disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 4 patient groups

Previous treatment, 0.16mg/kg

Active Comparator group

Description:

Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg

Treatment:

Drug: IMO-2055

Previous treatment, 0.64mg/kg

Active Comparator group

Description:

Patients will have clear cell renal carcinoma with previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg

Treatment:

Drug: IMO-2055

Treatment Naive, 0.16mg/kg

Active Comparator group

Description:

Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.16mg/kg

Treatment:

Drug: IMO-2055

Treatment Naive, 0.64mg/kg

Active Comparator group

Description:

Patients will have clear cell renal carcinoma without previous treatment. Patients will receive weekly SC injections of IMO-2055 at a dose of 0.64mg/kg

Treatment:

Drug: IMO-2055