Safety Study of CALAA-01 to Treat Solid Tumor Cancers
Status:
Terminated
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
Rationale: CALAA-01 is a targeted therapeutic designed to inhibit tumor growth and/or reduce
tumor size. The active ingredient in CALAA-01 is a small interfering RNA (siRNA). This siRNA
inhibits tumor growth via RNA interference to reduce expression of the M2 subunit of
ribonucleotide reductase (R2). The CALAA-01 siRNA is protected from nuclease degradation
within a stabilized nanoparticle targeted to tumor cells.
PURPOSE: This phase I trial will:
- Determine the safety, toxicity, and the maximum tolerated dose (MTD) of CALAA-01 when
administered intravenously to patients with relapsed or refractory cancer.
- Characterize the pharmacokinetics (PK) of CALAA-01 after intravenous administration.
- Provide preliminary evidence of efficacy of intravenous CALAA-01 by evaluating tumor
response.
- Recommend a dose of intravenous CALAA-01 for future clinical studies.
- Evaluate immune response, by measuring antibody and cytokine levels, and the effect of
intravenous CALAA-01 on complement.