About the study

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.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Participants who are diagnosed with one of the following, as defined by the World Health Organisation:
2. Peripheral T-cell Lymphoma
3. Classical Hodgkin Lymphoma
4. Eastern Cooperative Oncology Group performance status of ≤ 2.
5. Must have received at least 1 prior line of therapy for the treatment of current disease and have documented relapsed or refractory active disease requiring treatment, defined as:
6. Recurrence of disease after response to prior line(s) of therapy, or
7. Progressive disease after completion of or on the treatment regimen preceding entry into the study, or
8. Disease which did not achieve an objective response (CR or PR).
9. Uric acid level < ULN at screening. If hyperuricaemia is present at screening, SoC therapy should be administered (including IV fluid and rasburicase or allopurinol) to reduce the uric acid levels to < ULN before the start of study intervention.
10. Willing and able to participate in all required evaluations and procedures in this study protocol including receiving IV administration of study drug and being admitted, if required, for at least 24 hours during study drug administration.
11. Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.
12. Adequate haematologic function at screening.
13. PTCL Only: All participants with PTCL must be willing and able to provide mandatory baseline bone marrow aspirate and/or biopsy no older than 3 months, and agree to undergo post-treatment bone marrow biopsy when required to confirm response. Additional Module 1 Inclusion Criteria Prior lines of therapy:
14. PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.
15. Non NK-PTCL (Cohort 1): Prior therapy must have included an alkylating agent and/or anthracycline. In addition, ALCL participants must have received BV as part of prior therapy.
16. NKTCL (Cohort 2): Prior treatment must have included a platinum agent and/or asparaginase.
17. cHL (Cohort 3): Participants must have failed at least 2 prior therapies for the treatment of cHL (including BV and anti-PD1) except where unable to receive BV or anti-PD1 due to neuropathy or autoimmune disease.
18. Presence of at least 1 radiographically measurable, FDG-avid lymphoma disease lesion > 1.5 cm (according to the Lugano criteria [Cheson et al 2014]).

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.