AZD4573 as Monotherapy or in Combinations With Anti-cancer Agents in Patients With r/r PTCL or r/r cHL
NCT05140382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2024-08-28
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.
Conditions
- Relapsed/Refractory Peripheral T-cell Lymphoma
- Relapsed/Refractory Classical Hodgkins Lymphoma
Interventions
- DRUG
-
AZD4573
AZD4573 will be given intravenously
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 130 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-15
- Primary Completion
- 2023-08-25
- Completion
- 2024-02-16
- FDA Drug
- Yes
Countries
- United States
- Australia
- France
- Italy
- South Korea
- Sweden
- Taiwan
- United Kingdom
Study Locations
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