A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-toumor Activity AZD4205 in Patients with Peripheral T Cell Lymphoma (PTCL)

Description

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.

Resources and Links

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT04105010