Surovatamig (AZD0486) as Monotherapy in Participants With Relapsed/Refractory (R/R) B-cell NHL

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
AstraZeneca
Study ID
NCT06526793
Phase
PHASE2
Status
Recruiting
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Conditions

  • B-cell Non-Hodgkin Lymphoma
  • Follicular Lymphoma (FL)
  • Large B-Cell Lymphoma (LBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surovatamig — DRUG
    Investigational Product administered via intravenous infusion.

Study Details

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.

Key Dates

First listed
Jul 30, 2024
Start date
Nov 27, 2024
Status verified
Jun 2026
Primary completion
Nov 24, 2027
Completion
Oct 21, 2032

Study Design

Enrollment
270 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

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. ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Research SitePhoenixArizona85054-
Research SiteDuarteCalifornia91010-
Research SiteJacksonvilleFlorida32224-
Research SiteTampaFlorida33612-
Research SiteChicagoIllinois60637-
Research SiteIowa CityIowa52242-
Research SiteWaukeeIowa50263-
Research SiteOverland ParkKansas66204-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63110-
Research SiteNew BrunswickNew Jersey08901-
Research SiteNew YorkNew York10016-
Research SiteCharlotteNorth Carolina28204-
Research SiteColumbusOhio43210-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15232-
Research SitePittsburghPennsylvania15232-
Research SiteNashvilleTennessee37203-
Research SiteAustinTexas78704-
Research SiteHoustonTexas77030-
Research SiteSan AntonioTexas78229-
Research SiteMilwaukeeWisconsin53226-

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