This study is to determine the safety, pharmacokinetics/pharmacodynamics, and immunologic
impact of encapsulated rapamycin in patients with low risk prostate cancer under active
surveillance. There will be four groups of patients, each receiving a different dose of
rapamycin.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03618355.
This is a phase Ib trial of encapsulated rapamycin to determine safety,
pharmacokinetics/pharmacodynamics, and immunologic impact in patients with low risk
prostate cancer under active surveillance. This new formulation, encapsulated rapamycin
(sirolimus), provides a more predictable bioavailability of this drug than [the other
formulation]. The encapsulated and targeted rapamycin (eRapa) can be delivered at a
consistent and lower dosage, not only improving the toxicity profile but also
capitalizing on the newly appreciated mechanism of partial and/or intermittent mTOR
inhibition, making eRapa an ideal immuno-oncologic and chemopreventative agent. Low dose
rapamycin has been shown to prevent cancer formation, progression, and/or recurrence in
the majority of cancer histologies including the most prevalent: lung, breast, prostate,
and colon cancers.
Lead OrganizationEmtora Biosciences
