Acute Myeloid Leukemia Clinical Trial
Official title:
A Phase 1/1b Open-Label Study to Determine the Safety and Tolerability of ALRN-6924 Alone and in Combination With Cytarabine (Ara-C) in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome With Wild-Type TP53
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
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.
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