A Phase Ib/II, Multicentre, Open-label Study to Assess the Efficacy, Safety/ Tolerability and Pharmacokinetic of GFH009 Monotherapy in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
This is a multicentre, open-label phase Ib/II study. The purpose of the study is to assess the efficacy, safety/ tolerability and pharmacokinetic of GFH009 monotherapy in patients with relapsed or refractory peripheral T-cell lymphoma
• Male or female ≥ 18 years and ≤ 75 years.
• Written informed consent must be obtained prior to any screening procedures.
• Patients with histologically confirmed relapsed or refractory peripheral T-cell Lymphoma.
• Must have received and failed at least 2 but no more than 5 prior lines of therapies .
• Presence of at least 1 radiographically measurable lymphoma disease lesion (according to the Lugano criteria).
• Fresh tumor tissue or archival tumor tissue must be confirmed to be available at screening.
• Eastern Cooperative Oncology Group performance status of ≤ 2.
• Adequate haematologic and organ function at screening.
• Life expectancy ≥ 12 week.
⁃ Recovery to grade 0-1 from adverse events related to prior anti-tumor therapy except alopecia, fatigue and \< Grade 2 sensory neuropathy.
⁃ For women of childbearing potential, she must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug. Men with a partner of childbearing potential, must consent to use highly effective methods of contraception during GFH009 treatment and for an additional 90 days after the last administration of study drug