AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL

Summary

This is a modular dose confirmation and expansion study. The core study design is to assess the efficacy of AZD4573, administered as monotherapy or combination therapy, to participants with either r/r PTCL or r/r cHL and to confirm the safety profiles and PK in these populations. Module 1 of this study will evaluate the efficacy, safety, and tolerability of AZD4573 monotherapy in participants with r/r PTCL or r/r cHL. If AZD4573 monotherapy is found to have promising anti-tumour efficacy in Module 1, an AZD4573 monotherapy Phase II expansion may be added via a substantial protocol amendment.

Timeline

Start

2021-12-15

Primary completion

2023-08-25

Completion

2024-02-16

Outcome

Results reported · no primary-endpoint met/missed verdict (typical of a dose-finding / safety study)

release “Encouraging complete responses (CRs) observed with CDK9 inhibitor AZD4573 in Patients (pts) with Relapsed/Refractory (r/r) Peripheral T-cell Lymphoma (PTCL)” astrazeneca.com ↗

Drugs

Indications