A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of AZD0486 in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)

Status: Recruiting
Location: See all (86) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of AZD0486 monotherapy in adult participants with relapsed/refractory B-cell non-Hodgkin lymphoma (NHL) who have received at least two prior lines of therapies. The study has 2 Modules: Module 1 for FL and Module 2 for DLBCL.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

‣ Aged 18 to 80 years old

⁃ Histologically confirmed relapsed refractory FL (Module 1) and DLBCL (Module 2) after at least 2 prior lines of therapy

⁃ ECOG performance status 0 to 2

⁃ Locally confirmed CD-19 expression in lymphoma cells after progression from last CD 19 directed therapy

⁃ FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as \> 1.5 cm in its longest dimension), or extranodal lesion (defined as \> 1.0 cm in its longest dimension)

⁃ Adequate hematological function: ANC ≥ 1000/mm3, platelets

∙ 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening

⁃ Adequate liver function: total bilirubin \<1.5x ULN, AST/ALT ≤ 3xULN Note: Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible)

⁃ Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min

• The above is a summary, other inclusion criteria details may apply.

Locations
United States
California
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RECRUITING
Duarte
Florida
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NOT_YET_RECRUITING
Tampa
Iowa
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NOT_YET_RECRUITING
Des Moines
Kansas
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WITHDRAWN
Overland Park
Minnesota
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NOT_YET_RECRUITING
Rochester
Missouri
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St Louis
North Carolina
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NOT_YET_RECRUITING
Charlotte
New Jersey
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New Brunswick
New York
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NOT_YET_RECRUITING
New York
Ohio
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Columbus
Oregon
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Portland
Pennsylvania
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NOT_YET_RECRUITING
Philadelphia
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Pittsburgh
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Pittsburgh
Texas
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NOT_YET_RECRUITING
Houston
Wisconsin
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NOT_YET_RECRUITING
Milwaukee
Other Locations
Australia
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RECRUITING
Heidelberg
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Kogarah
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Macquarie University
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Nedlands
Brazil
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NOT_YET_RECRUITING
Porto Alegre
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São Paulo
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São Paulo
Canada
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NOT_YET_RECRUITING
Barrie
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Brampton
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Ottawa
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Toronto
China
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Chengdu
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Chengdu
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Guangzhou
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NOT_YET_RECRUITING
Nanchang
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Nanjing
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Nantong
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Shandong
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NOT_YET_RECRUITING
Shanghai
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NOT_YET_RECRUITING
Tianjin
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NOT_YET_RECRUITING
Zhengzhou
Denmark
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WITHDRAWN
Aalborg
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RECRUITING
Copenhagen
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NOT_YET_RECRUITING
Vejle
France
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NOT_YET_RECRUITING
Montpellier
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NOT_YET_RECRUITING
Paris
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RECRUITING
Pierre-bénite
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NOT_YET_RECRUITING
Rouen
Germany
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NOT_YET_RECRUITING
Berlin
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Chemnitz
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Essen
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NOT_YET_RECRUITING
Jena
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RECRUITING
Würzburg
Hong Kong Special Administrative Region
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NOT_YET_RECRUITING
Hong Kong
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NOT_YET_RECRUITING
Shatin
Italy
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NOT_YET_RECRUITING
Alessandria
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NOT_YET_RECRUITING
Bologna
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NOT_YET_RECRUITING
Busto Arsizio
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NOT_YET_RECRUITING
Milan
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RECRUITING
Milan
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NOT_YET_RECRUITING
Roma
Japan
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Chiba
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NOT_YET_RECRUITING
Kashiwa
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Kōtoku
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Kumamoto
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Niigata
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Okayama
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Osaka
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Yokohama
Republic of Korea
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NOT_YET_RECRUITING
Seoul
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Seoul
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Seoul
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Seoul
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Seoul
Spain
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NOT_YET_RECRUITING
Barcelona
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NOT_YET_RECRUITING
Madrid
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NOT_YET_RECRUITING
Pozuelo De Alarcón
Sweden
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NOT_YET_RECRUITING
Gothenburg
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NOT_YET_RECRUITING
Stockholm
Taiwan
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WITHDRAWN
Kaohsiung City
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RECRUITING
Kaohsiung City
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RECRUITING
Taichung
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Taichung
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Tainan City
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Taipei
United Kingdom
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NOT_YET_RECRUITING
London
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Manchester
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Norwich
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Nottingham
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NOT_YET_RECRUITING
Plymouth
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-11-27
Estimated Completion Date: 2029-06-14
Participants
Target number of participants: 240
Treatments
Experimental: Module 1: AZD0486 Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma
In Module 1, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R FL. AZD0486 will be administered as intravenous infusion.
Experimental: Module 2: AZD0486 Monotherapy in Participants with Relapsed or Refractory DLBCL
In Module 2, the efficacy and safety of AZD0486 at the RP2D will be evaluated in R/R DLBCL. AZD0486 will be administered as intravenous infusion.
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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