Trial Identifiers
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Scientific Title
A Phase I/II, Open-Label, Multicentre Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD4205 in Patients With Peripheral T Cell Lymphoma (PTCL)
Commercial Sponsor
Dizal Pharmaceuticals
Summary
This is a non-randomised trial with two phases. Phase 1 involves around 20-40 participants being subsequently enrolled into 2 different dose ascending cohorts. An additional 10-20 participants may be enrolled to further explore a selected dose defined by dose escalation cohorts. After the recommended phase 2 dose (RP2D) is defined, a phase 2 dingle-arm, open-label pivotal study will be conducted to assess anti-tumour efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.