Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the
safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with
peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to
standard systemic treatment.
Phase 1 part:
Around 20~40 patients will be subsequently enrolled into 2 different dose ascending cohorts.
Additional 10~20 patients may be enrolled to further explore a selected dose defined by dose
escalation cohorts.
Phase 2 part:
After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal
study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in
patients with refractory or relapsed PTCL.