- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06526793
Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL (SOUNDTRACK-B)
A Modular Phase 2, Single-arm, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Surovatamig (AZD0486) in Participants With Relapsed or Refractory (R/R) B-cell Non-Hodgkin Lymphoma (SOUNDTRACK-B)
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: AstraZeneca Clinical Study Information Center
- Phone Number: 1-877-240-9479
- Email: information.center@astrazeneca.com
Study Locations
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Heidelberg, Australia, 3084
- Recruiting
- Research Site
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Kogarah, Australia, NSW 2217
- Recruiting
- Research Site
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Macquarie University, Australia, 2109
- Recruiting
- Research Site
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Nedlands, Australia, 6009
- Recruiting
- Research Site
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Porto Alegre, Brazil, 90035903
- Withdrawn
- Research Site
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São Paulo, Brazil, 05652-900
- Recruiting
- Research Site
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São Paulo, Brazil, 01401-002
- Recruiting
- Research Site
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Ontario
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Barrie, Ontario, Canada, L4M 6M2
- Withdrawn
- Research Site
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Brampton, Ontario, Canada, L6R 3J7
- Recruiting
- Research Site
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Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- Research Site
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Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Research Site
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Chengdu, China, 610041
- Recruiting
- Research Site
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Chengdu, China, 610072
- Recruiting
- Research Site
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Guangzhou, China, 510060
- Recruiting
- Research Site
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Nanchang, China, 330029
- Recruiting
- Research Site
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Nanjing, China, 210029
- Recruiting
- Research Site
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Nantong, China, 226001
- Recruiting
- Research Site
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Shandong, China
- Recruiting
- Research Site
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Shanghai, China, 200025
- Recruiting
- Research Site
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Shanghai, China, 200032
- Recruiting
- Research Site
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Tianjin, China, 300020
- Recruiting
- Research Site
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Zhengzhou, China, 450008
- Recruiting
- Research Site
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Aalborg, Denmark, 9100
- Withdrawn
- Research Site
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Copenhagen, Denmark, 2100
- Recruiting
- Research Site
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Vejle, Denmark, 7100
- Recruiting
- Research Site
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Montpellier, France, 34295
- Recruiting
- Research Site
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Paris, France, 75010
- Recruiting
- Research Site
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Pierre-Bénite, France, 69495
- Recruiting
- Research Site
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Rouen, France, 76038
- Recruiting
- Research Site
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Berlin, Germany, 10967
- Recruiting
- Research Site
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Chemnitz, Germany, 9116
- Recruiting
- Research Site
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Essen, Germany, 45147
- Recruiting
- Research Site
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Jena, Germany, 07747
- Recruiting
- Research Site
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Würzburg, Germany, 97080
- Recruiting
- Research Site
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Hong Kong, Hong Kong, 999077
- Recruiting
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Shatin, Hong Kong
- Recruiting
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Alessandria, Italy, 15121
- Recruiting
- Research Site
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Bologna, Italy, 40138
- Recruiting
- Research Site
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Busto Arsizio, Italy, 21052
- Recruiting
- Research Site
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Milan, Italy, 20132
- Recruiting
- Research Site
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Milan, Italy, 20141
- Recruiting
- Research Site
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Roma, Italy, 161
- Withdrawn
- Research Site
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Chiba, Japan, 260-8717
- Recruiting
- Research Site
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Kashiwa, Japan, 277-8577
- Recruiting
- Research Site
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Kumamoto, Japan, 860-0008
- Recruiting
- Research Site
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Kōtoku, Japan, 135-8550
- Recruiting
- Research Site
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Niigata, Japan, 951-8520
- Recruiting
- Research Site
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Okayama, Japan, 700-8558
- Recruiting
- Research Site
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Osaka, Japan, 541-8567
- Recruiting
- Research Site
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Yokohama, Japan, 241-8515
- Recruiting
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Seoul, South Korea, 03080
- Recruiting
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Seoul, South Korea, 06351
- Recruiting
- Research Site
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Seoul, South Korea, 5505
- Recruiting
- Research Site
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Seoul, South Korea, 06591
- Recruiting
- Research Site
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Seoul, South Korea, 3722
- Recruiting
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Barcelona, Spain, 08035
- Recruiting
- Research Site
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Madrid, Spain, 28040
- Recruiting
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Pozuelo de Alarcón, Spain, 28223
- Recruiting
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Gothenburg, Sweden, 41345
- Recruiting
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Stockholm, Sweden, 17176
- Recruiting
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Kaohsiung City, Taiwan, 833401
- Recruiting
- Research Site
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Kaohsiung City, Taiwan, 80756
- Withdrawn
- Research Site
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Taichung, Taiwan, 40705
- Recruiting
- Research Site
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Taichung, Taiwan, 404
- Recruiting
- Research Site
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Tainan, Taiwan, 70403
- Recruiting
- Research Site
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Taipei, Taiwan, 106
- Recruiting
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London, United Kingdom, SE5 9RS
- Recruiting
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Manchester, United Kingdom, M20 4BX
- Recruiting
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Norwich, United Kingdom, NR4 7UY
- Recruiting
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Nottingham, United Kingdom, NG5 1PB
- Recruiting
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Plymouth, United Kingdom, PL6 8DH
- Recruiting
- Research Site
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Arizona
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Phoenix, Arizona, United States, 85054
- Withdrawn
- Research Site
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California
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Duarte, California, United States, 91010
- Recruiting
- Research Site
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Florida
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Jacksonville, Florida, United States, 32224
- Withdrawn
- Research Site
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Tampa, Florida, United States, 33612
- Recruiting
- Research Site
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- Research Site
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Iowa
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Iowa City, Iowa, United States, 52242
- Withdrawn
- Research Site
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Waukee, Iowa, United States, 50263
- Recruiting
- Research Site
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Kansas
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Overland Park, Kansas, United States, 66204
- Withdrawn
- Research Site
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Minnesota
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Rochester, Minnesota, United States, 55905
- Recruiting
- Research Site
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Missouri
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St Louis, Missouri, United States, 63110
- Withdrawn
- Research Site
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New Jersey
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New Brunswick, New Jersey, United States, 08901
- Withdrawn
- Research Site
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New York
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New York, New York, United States, 10016
- Recruiting
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Recruiting
- Research Site
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Ohio
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Columbus, Ohio, United States, 43210
- Recruiting
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Oregon
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Portland, Oregon, United States, 97239
- Recruiting
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Research Site
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Pittsburgh, Pennsylvania, United States, 15232
- Withdrawn
- Research Site
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Pittsburgh, Pennsylvania, United States, 15232
- Recruiting
- Research Site
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Research Site
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Texas
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Austin, Texas, United States, 78704
- Recruiting
- Research Site
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Houston, Texas, United States, 77030
- Recruiting
- Research Site
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San Antonio, Texas, United States, 78229
- Not yet recruiting
- Research Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Recruiting
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Key Inclusion Criteria:
- Aged 18 years old and above
- Histologically confirmed relapsed refractory FL (Module 1) and LBCL (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 or < 5 × ULN in the presence of lymphoma involvement of the liver
- Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min
- Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA
The above is a summary, other inclusion criteria details may apply.
Key Exclusion Criteria:
- Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
- Active CNS involvement by B-NHL
- Leukemic presentation of B-NHL
- History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic, or that the treating investigator considers to have the potential to interfere with the evaluation of safety, such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis or other severe mental illness.
- Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig
- Requires chronic immunosuppressive therapy
- Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
- History of major cardiac abnormalities.
- If female, participant must not be pregnant or breastfeeding.
The above is a summary, other exclusion criteria details may apply.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma
In Module 1, the efficacy and safety of surovatamig at the RP2D will be evaluated in R/R FL.
Surovatamig will be administered as intravenous infusion.
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Investigational Product administered via intravenous infusion.
Other Names:
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Experimental: Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL
In Module 2, the efficacy and safety of surovatamig at the RP2D will be evaluated in R/R LBCL.
Surovatamig will be administered as intravenous infusion.
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Investigational Product administered via intravenous infusion.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Overall response rate (ORR) (central review)
Time Frame: Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months.
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Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a Partial Response (PR) or Complete Response (CR) based on Lugano 2014 response criteria for non-Hodgkin Lymphoma, as determined by central review
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Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to approximately 12 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Duration of response (DoR)
Time Frame: To be assessed up to approximately 5 years.
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Defined as the time from the date of first documented response until date of documented progression by Lugano 2014 response criteria as determined by central review or death due to any cause.
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To be assessed up to approximately 5 years.
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Time to response (TTR)
Time Frame: From the first dose until the first objective response, up to approximately 5 years.
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Defined as the time from first dose until first documented objective response, as assessed by central review.
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From the first dose until the first objective response, up to approximately 5 years.
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Event-free survival (EFS)
Time Frame: To be assessed up to approximately 5 years
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Defined as the time from first dose until disease progression, relapse, or initiation of subsequent systemic anti-lymphoma treatment, or death due to any cause, as assessed by central review.
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To be assessed up to approximately 5 years
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Progression-free survival (PFS)
Time Frame: To be assessed up to approximately 5 years.
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Defined as the time from the date of first dose until documented disease progression based on Lugano 2014 Response Criteria, or death due to any cause.
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To be assessed up to approximately 5 years.
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Overall survival (OS)
Time Frame: To be assessed up to approximately 5 years.
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Defined as the time from first dose until the date of death due to any cause.
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To be assessed up to approximately 5 years.
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Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI)
Time Frame: From time of Informed Consent to 90-day safety follow-up visit
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Incidence, nature, and severity of AEs/SAEs (based on NCI CTCAE v5.0/ASTCT criteria/Cairo-Bishop criteria with Howard modification) and changes in laboratory data, vital signs, and electrocardiograms (ECGs) compared with baseline. Incidence and severity of AESIs. |
From time of Informed Consent to 90-day safety follow-up visit
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Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs)
Time Frame: From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2
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Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs
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From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2
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Complete response (CR) rate (central review)
Time Frame: To be assessed up through study completion, up to approximately 5 years
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Complete response (CR) based on Lugano 2014 Response criteria for non-Hodgkin lymphoma, as determined by central review.
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To be assessed up through study completion, up to approximately 5 years
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Complete response (CR) rate (investigator assessment)
Time Frame: To be assessed up through study completion, up to approximately 5 years
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Complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.
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To be assessed up through study completion, up to approximately 5 years
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Duration of complete response (DoCR)
Time Frame: To be assessed up to approximately 5 years.
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Defined as the time from achievement of complete response (CR) to relapse or death due any cause, as assessed by central review
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To be assessed up to approximately 5 years.
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Plasma concentrations of surovatamig
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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To characterize the plasma concentration of surovatamig as monotherapy
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From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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Area under the concentration time curve (AUC)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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To characterize the pharmacokinetics (PK) AUC of surovatamig as monotherapy
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From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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Maximum plasma concentration (Cmax)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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To characterize the pharmacokinetics (PK) (Cmax) of surovatamig as monotherapy
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From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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Time to maximum plasma concentration (Tmax)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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To characterize the pharmacokinetics (PK) (Tmax) of surovatamig as monotherapy
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From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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A trough concentration (Cthrough)
Time Frame: From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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To characterize the pharmacokinetics (PK) (C through) of surovatamig as monotherapy
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From Cycle 1 Day 1 (pre-dose) (each cycle is 28 days) up to 90 days after end of treatment
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Immunogenecity of surovatamig
Time Frame: From the first dose of study intervention, at predefined intervals throughout the administration of surovatamig (2 years in Module 1 and 1 year in Module 2)
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The number and percentage of participants who develop Anti-Drug Antibodies (ADAs)
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From the first dose of study intervention, at predefined intervals throughout the administration of surovatamig (2 years in Module 1 and 1 year in Module 2)
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Change from baseline in FACT-LymS scales
Time Frame: To be assessed up through study completion, up to approximately 5 years
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To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns, while on surovatamig Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) FACT-LymS - Lymphoma-specific Subscale from the FACT-Lym Questionnaire is a 15-item questionnaire, and each item is rated on a 5-point scale ranging from 0 (not at all) to 4 (very much). |
To be assessed up through study completion, up to approximately 5 years
|
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Overall response rate (ORR) (investigator assessment)
Time Frame: Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
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Overall response summarized via overall response rate (ORR), defined as the proportion of participants achieving either a partial response (PR) or complete response (CR) based on Lugano 2014 Response criteria of non-Hodgkin lymphoma, as determined by investigator assessment.
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Module 1: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 24 months. Module 2: from first dose to end of treatment or data cutoff, whichever comes first, assessed up to about 12 months.
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Time to next anti-lymphoma (TTNT)
Time Frame: To be assessed up to approximately 5 years.
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Defined as time from first dose until the start date of subsequent anti-lymphoma therapy or death due to any cause.
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To be assessed up to approximately 5 years.
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Change from baseline in EORTC IL233 scales
Time Frame: To be assessed up through study completion, up to approximately 5 years
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To evaluate patient-reported tolerability of surovatamig, including severity of key treatment-related symptoms and overall side-effect burden. IL233 will evaluate different levels of severity in fatigue, pain and cognition. EORCT IL233 scales - European Organisation for Research and Treatment of Cancer Il233 scales- this questionnaire is assessing Patient-reported Severity of Treatment-and Disease-related Symptoms, it is a 15-item questionnaire, and each item is rated on a 4-point scale ranging from 1 (not at all) to 4 (very much). |
To be assessed up through study completion, up to approximately 5 years
|
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Change from baseline in PGI-TT scale
Time Frame: To be assessed up through study completion, up to approximately 5 years
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To evaluate patient-reported tolerability of surovatamig, overall side-effect burden. PGI-TT scale - Patient Global Impression of Treatment Tolerability is a 1 item questionnaire rated on a 7-point scale ranging from "not at all" to "very much" |
To be assessed up through study completion, up to approximately 5 years
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Change from baseline in EORTC IL 232 QL2 scores
Time Frame: To be assessed up through study completion, up to approximately 5 years
|
To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns, while on surovatamig. European Organization for Research and Treatment of Cancer (EORTC) IL 232 will be used to evaluate impacts on function and HRQoL (health-related quality of life) due to treatment and disease, which includes 13 EORTC QLQ-C30 function items assessing physical, social, role, and emotional function, as well as the EORTC QLQ-C30's 2 global health/HRQoL items. |
To be assessed up through study completion, up to approximately 5 years
|
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Minimal residual disease (MRD)
Time Frame: To be assessed up through study completion, up to approximately 5 years
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MRD-negative complete response (CR) summarized through MRD-negative rate, defined as the proportion of participants who achieved MRD-negativity in plasma by next generation sequencing (NGS) while in complete response (CR) per the Lugano Response criteria for non-Hodgkin lymphoma as determined by central review.
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To be assessed up through study completion, up to approximately 5 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms
- Disease Attributes
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Lymphoma
- Pathological Conditions, Signs and Symptoms
- Hemic and Lymphatic Diseases
- Recurrence
- Lymphoma, B-Cell
- Lymphoma, Non-Hodgkin
- Lymphoma, Follicular
Other Study ID Numbers
- D7404C00001
- 2023-505789-27-00 (Registry Identifier: CTIS (EU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.