Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
This is a Phase 2 global, multi-center, open-label study to assess the efficacy, safety and tolerability of surovatamig (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 LBCL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Surovatamig
DrugInvestigational Product administered via intravenous infusion.
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular LymphomaExperimental treatment 1 intervention
Group B: Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCLExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Overall response rate (ORR) (central review)
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
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.Secondary outcomes
1
Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI)
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.
Time frame
From time of Informed Consent to 90-day safety follow-up visit2
Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs)
Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs
Time frame
From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 23
Duration of response (DoR)
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.
Time frame
To be assessed up to approximately 5 years.4
Complete response (CR) rate (central review)
Complete response (CR) based on Lugano 2014 Response criteria for non-Hodgkin lymphoma, as determined by central review.
Time frame
To be assessed up through study completion, up to approximately 5 yearsSponsors and contacts
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Source ClinicalTrials.gov