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.
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To determine the tolerability, safety profile and maximum tolerated dose (MTD) of intravenous CALAA-01.
Timeframe: 3 months