Phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to
evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics) and
anti-tumor effects of ALRN-6924 alone or in combination with cytarabine in patients with
relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with
wild-type (WT) TP53
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02909972.
Phase I, open label, multi-center dose escalation (DEP) and dose expansion (EXP) study
designed to evaluate safety, tolerability, PK (pharmacokinetics), PD (pharmacodynamics)
and anti-tumor effects of ALRN-6924 in patients with acute myeloid leukemia or advanced
myelodysplastic syndrome with wild-type (WT) TP53. ALRN-6924 is a stabilized
cell-permeating peptide designed to disrupt interaction between the p53 tumor suppression
protein and its endogenous inhibitors murine double minute 2 (MDM2) and murine double
minute X (MDMX)
Men and women 18 years of age and older with relapsed or refractory acute myeloid
leukemia or advanced myelodysplastic syndrome and for which standard treatment(s) are not
available or are no longer effective can be enrolled. Treatment of patients in the DEP
and EXP phases will continue in the study until documentation of disease progression,
unacceptable toxicity, or patient or physician decision to discontinue study
participation is made.
Lead OrganizationAileron Therapeutics, Inc.
