A Phase II, Open-Label, Single-Arm Study to Investigate the Safety, Tolerability, and Anti-tumor Activity of AZD4205 Treating Relapsed or Refractory Peripheral T Cell Lymphoma (r/r PTCL)
This is a phase II, open label, multicenter study of AZD4205 administered orally in participants with r/r PTCL to determine its safety, tolerability, PK, and anti-tumor activity. Eligible participants are those who had pathologically confirmed PTCL and have relapsed after or been refractory/intolerant to at least one prior systemic treatment regimen. The primary objective of this study is to evaluate anti-tumor efficacy of AZD4205 at 150 mg once daily (RP2D) in participants with r/r PTCL. The safety, tolerability, and PK of AZD4205 in r/r PTCL at RP2D will also be investigated.
• ≥ 18 years old (for Korean ≥ 19 years old)
• ECOG performance status 0-2 with no deterioration over the previous 2 weeks
• Predicted life expectancy ≥ 12 weeks.
• Histologically confirmed PTCL by local pathology review according to the 2016 revision of the WHO classification of lymphoid neoplasms. Eligible histological subtypes are restricted to the following:
‣ PTCL-NOS
⁃ AITL
⁃ ALCL ALK+
⁃ EATL
⁃ MEITL
⁃ NKTCL
⁃ HSTCL
⁃ SPTCL
• Have measurable disease according to the 2014 Lugano classification
• Must have progressed on or are refractory to standard systemic therapy, or patients were intolerant to standard systemic therapy. Participants should be transplant-ineligible upon their entries to this study.
• Adequate bone marrow reserve and organ system functions
• LVEF ≥ 55% assessed by ECHO or MUGA.
• Male participant with female partners of child-bearing potential should be willing to use barrier contraceptives (i.e., by use of condoms), during his participation in this study and for 6 months following the last dose of the study drug. Male participant must refrain from donating sperm during their participation in the study and at least for 6 months after the last treatment.
⁃ Female participant should be using adequate contraceptive measures while on study drug and for 3 months following the last dose of study drug.