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.
Age range
18 Years
Sex
ALL
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
To determine the tolerability, safety profile and maximum tolerated dose (MTD) of intravenous CALAA-01.
Timeframe: 3 months