AZD0486
DrugBispecific monoclonal IgG4 antibody
Other names: TNB-486
Recruiting
NCT Number: NCT07215585
AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
65 year–130 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
Research Site, Clayton, Australia
Loading trial locations.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;
- Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
- FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
- Stage I bulky (7.5 cm and greater) to Stage IV;
- ECOG performance status 0 to 2;
- Adequate bone marrow, liver, renal and cardiac function.
The above is a summary, other inclusion criteria details may apply.
- As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol
- Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).
- History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition
- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
- Active or uncontrolled infection
- Major cardiac abnormalities
- Prior anti-lymphoma therapy except for corticosteroids for symptom control
- Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions
The above is a summary, other exclusion criteria details may apply.
Treatment and study plan
R-mini-CHOP
DrugIntravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2
Primary outcomes
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SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 1 year
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
-
SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 1 year
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
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SRI - Determination of the recommended Phase III dose (RP3D)
Time frame: Up to 1 year
The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the Safety Run-In part
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Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen.
Time frame: Up to 7 years
Progression-free Surival (PFS), based on Lugano 2014 Response Criteria.
Secondary outcomes
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Safety Run-In and Phase 3 - ORR
Time frame: Up to 7 years
ORR defined as the proportion of participants achieving either a PR or CR at timepoints defined in the study protocol, based on Lugano 2014 Response Criteria as determined by Investigator assessment.
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Safety Run-In and Phase 3 - CR Rate
Time frame: Up to 7 years
CR rate is defined as the proportion of participants achieving a CR at timepoints defined in the study protocol, based on Lugano 2014 Response Criteria as determined by Investigator assessment.
-
Safety Run-In and Phase 3 - DoR
Time frame: Up to 7 years
DoR is defined as the time from the date of first documented response until the date of documented progression based on Lugano 2014 criteria as determined by Investigator assessment or death due to any cause.
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Safety Run-In and Phase 3 - DoCR
Time frame: Up to 7 years
DoCR is defined as the time from the date of first documented CR until the date of documented progression or death due to any cause, as assessed by the Investigator.
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Safety Run-In and Phase 3 - PFS
Time frame: Up to 7 years
PFS is defined as the time from date of the first dose to date of documented objective disease progression as per Lugano 2014 or death (by any cause in the absence of progression), as determined by Investigator assessment.
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Safety Run In and Phase 3 - OS
Time frame: Up to 7 years
OS defined as the time from date of the first dose until death due to any cause.
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Phase 3 - Time from randomisation to second progression or death (PFS2)
Time frame: Up to 7 years
PFS2 is defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.
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Phase 3 - Time to First Subsequent Therapy or Death (TFST)
Time frame: Up to 7 Years
TFST is defined as time from randomisation until the start date of first subsequent anti-lymphoma therapy after discontinuation of randomised treatment, or death due to any cause.
-
Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 7 years
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
-
Phase 3 - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 7 years
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
-
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: serum concentration of study drug
Time frame: Up to 7 years
Maximum observed serum concentration of AZD0486.
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Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Maximum plasma concentration of the study drug (Cmax).
Time frame: Up to 7 years
Maximum observed plasma concentration of AZD0486.
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Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Concentration of study drug reached before next dose (Ctrough).
Time frame: Up to 7 years
Observed plasma concentration of AZD0486 right before next dose of AZD0486.
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Safety Run-In and Phase 3 - To determine the immunogenicity of AZD0486
Time frame: Up to 7 years
Summary of pre-existing and treatment induced ADAs for AZD0486 (positive or negative, titres) and the impact on PK, efficacy or safety.
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Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486 versus R-mini-CHOP × 6
Time frame: Up to 7 years
Evaluation of key participant-reported side effects (pain, fatigue) and overall treatment tolerability, lymphoma-specific concerns, and HRQoL.
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Phase 3 - Efficacy evaluation of R-mini-CHOP × 2 followed by AZD0486 versus R-mini-CHOP × 6
Time frame: Up to 7 years
Evaluation of key participant-reported side effects (pain, fatigue) and overall treatment tolerability, lymphoma-specific concerns, and HRQoL.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
AstraZeneca
Industry
Registry information
Official study title
A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
Acronym: SOUNDTRACK-D2
Important dates
- Study start
- 2025
- Primary completion
- 2030
- Study completion
- 2033
- First posted
- Oct 10, 2025
- Registry last updated
- Jun 18, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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