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

NCT05140382 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: D8231C000012021-002570-54
• Study Type: interventional
• Target: 52
• Locations: 8 countries
• Sites: 27

Brief 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

Keywords

AZD4573; Modular study; Dose confirmation; Dose expansion

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective response rate is defined as the proportion of participants who have a tumour response of complete response \[CR\] or partial response \[PR\] according to the Lugano (2014) response criteria for malignant lymphoma.

  From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months)

Secondary Outcomes (13)

• Complete Response (CR) Rate

  From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).

• Duration of Response (DoR)

  From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).

• Progression-free Survival (PFS)

  From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).

• Overall Survival (OS)

  From Screening (Day -30 to Day-1) until disease progression or survival until death (26 months).

• Number of Participants With Adverse Events (AE) and Serious AEs (SAE)

  From treatment period (Cycle 1) to follow up visit (30 [± 7] ) days from the last dose (upto 26 months).

Study Arms (1)

AZD4573 (Monotherapy)

EXPERIMENTAL

Eligible participants with either r/r PTCL, r/r NKTCL or r/r cHL will receive AZD4573 as monotherapy.

Drug: AZD4573

Interventions

AZD4573 DRUG

AZD4573 will be given intravenously

AZD4573 (Monotherapy)

Eligibility Criteria

• Age: 18 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are diagnosed with one of the following, as defined by the World Health Organisation:
• Peripheral T-cell Lymphoma
• Classical Hodgkin Lymphoma
• Eastern Cooperative Oncology Group performance status of ≤ 2.
• 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:
• Recurrence of disease after response to prior line(s) of therapy, or
• Progressive disease after completion of or on the treatment regimen preceding entry into the study, or
• Disease which did not achieve an objective response (CR or PR).
• 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.
• 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.
• Fresh tumour tissue or archival tumour tissue must be confirmed to be available at screening.
• Adequate haematologic function at screening.
• PTCL Only: All participants with PTCL must be willing and able to provide 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.
• Prior lines of therapy:
• PTCL: Participants must have failed at least 1 prior therapy for the treatment of PTCL.

You may not qualify if:

• Type of Participant and Disease Characteristics:
• PTCL only: Presence of bulky disease (defined as largest lymphoma lesion ≥ 10 cm) or a LDH value \> 3 x ULN.
• PTCL only: Diagnosis of any of the following: Lymphoblastic/precursor T-cell lymphoma or leukaemia; T-cell prolymphocytic leukaemia; T-cell large granular lymphocytic leukaemia; Cutaneous T-cell lymphoma (eg, primary cutaneous type ALCL, mycosis fungoide/Sezary syndrome).
• Medical Conditions:
• With the exception of alopecia and neuropathy, presence of any unresolved non haematological toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment.
• Presence of, or history of, CNS lymphoma, leptomeningeal disease, or spinal cord compression.
• History of prior non-haematological malignancy except for the following:
• Malignancy treated with curative intent and with no evidence of active disease present for more than 1 year prior to screening and felt to be at low risk for recurrence by treating physician.
• Adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer.
• Adequately treated carcinoma in situ without current evidence of disease.
• Any evidence of:
• Severe or uncontrolled systemic disease (eg, severe hepatic impairment, interstitial lung disease \[bilateral, diffuse, parenchymal lung disease\]).
• Current unstable or uncompensated respiratory or cardiac conditions.
• Uncontrolled hypertension.
• Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (27)

Research Site

Duarte, California, 91010, United States

Location

Research Site

Boston, Massachusetts, 02215, United States

Location

Research Site

Hackensack, New Jersey, 07601, United States

Location

Research Site

Houston, Texas, 77030, United States

Location

Research Site

Salt Lake City, Utah, 84112, United States

Location

Research Site

Seattle, Washington, 98104, United States

Location

Research Site

Clayton, 3168, Australia

Location

Research Site

Melbourne, 3000, Australia

Location

Research Site

Nedlands, 6009, Australia

Location

Research Site

Besançon, 25000, France

Location

Research Site

Clermont-Ferrand, 63003, France

Location

Research Site

Créteil, 94010, France

Location

Research Site

Lille, 59037, France

Location

Research Site

Montpellier, 34295, France

Location

Research Site

Bologna, 40138, Italy

Location

Research Site

Napoli, 80131, Italy

Location

Research Site

Seoul, 03080, South Korea

Location

Research Site

Seoul, 03722, South Korea

Location

Research Site

Seoul, 05505, South Korea

Location

Research Site

Seoul, 06351, South Korea

Location

Research Site

Lund, 221 85, Sweden

Location

Research Site

Kaohsiung City, 83301, Taiwan

Location

Research Site

Taichung, 40447, Taiwan

Location

Research Site

Tainan, 70403, Taiwan

Location

Research Site

Taipei, 100, Taiwan

Location

Research Site

Headington, 0X3 7LJ, United Kingdom

Location

Research Site

London, NW1 2PG, United Kingdom

Location

Related Links

• CSP redacted
• SAP redacted
• CSR Synopsis redacted

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca

information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 1, 2021
• Study Start: December 15, 2021
• Primary Completion: August 25, 2023
• Study Completion: February 16, 2024
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Locations

US (6); GB (2); FR (5); AU (3); KR (4); SE (1); IT (2); TW (4)