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

Conditions

Relapsed or Refractory Non-Hodgkin Lymphoma

Brief summary

ORR, defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response Criteria as determined by an IRC

Detailed description

1. Safety and tolerability of surovatamig - incidence, nature, and severity of AEs/SAEs/AESI, changes in laboratory data, vital signs, and ECGs compared with baseline, incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs, 2. Efficacy - DoR and CR, ORR and CR rates, 3. Efficacy - DoCR, TTR, EFS, PFS, TTNT, OS, 4. PK - PK parameters such as such as Cmax, Tmax, Ctrough of surovatamig (at predefined intervals), 5. Immunogenicity -pre-existing and induced ADA for surovatamig, 6. PROs - difference in severity levels in fatigue, pain, cognition and overall side-effect burden, 7. MRD-negative CR rate

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGAZD0486

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR, defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response Criteria as determined by an IRC	—

Secondary

Measure	Time frame
1. Safety and tolerability of surovatamig - incidence, nature, and severity of AEs/SAEs/AESI, changes in laboratory data, vital signs, and ECGs compared with baseline, incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs, 2. Efficacy - DoR and CR, ORR and CR rates, 3. Efficacy - DoCR, TTR, EFS, PFS, TTNT, OS, 4. PK - PK parameters such as such as Cmax, Tmax, Ctrough of surovatamig (at predefined intervals), 5. Immunogenicity -pre-existing and induced ADA for surovatamig, 6. PROs - difference in severity levels in fatigue, pain, cognition and overall side-effect burden, 7. MRD-negative CR rate	—

Measure

Time frame

1. Safety and tolerability of surovatamig - incidence, nature, and severity of AEs/SAEs/AESI, changes in laboratory data, vital signs, and ECGs compared with baseline, incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs, 2. Efficacy - DoR and CR, ORR and CR rates, 3. Efficacy - DoCR, TTR, EFS, PFS, TTNT, OS, 4. PK - PK parameters such as such as Cmax, Tmax, Ctrough of surovatamig (at predefined intervals), 5. Immunogenicity -pre-existing and induced ADA for surovatamig, 6. PROs - difference in severity levels in fatigue, pain, cognition and overall side-effect burden, 7. MRD-negative CR rate

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Countries

Denmark, France, Germany, Italy, Spain, Sweden

Outcome results

None listed