A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
AstraZeneca
Study ID
NCT06564038
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • B-cell Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukaemia
  • Large B-cell Lymphoma
  • Mantle-cell Lymphoma
  • Small Lymphocytic Lymphoma

Eligibility Criteria

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

Interventions

  • Surovatamig — DRUG
    Surovatamig will be administered as either SC injection or IV infusion.
  • Prednisone (or equivalent) — DRUG
    Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
  • Rituximab — DRUG
    Rituximab will be administered as IV infusion as per standard of care.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be administered as IV infusion as per standard of care.
  • Vincristine — DRUG
    Vincristine will be administered as IV infusion as per standard of care.
  • Doxorubicin — DRUG
    Doxorubicin will be administered as IV infusion as per standard of care.
  • Acalabrutinib — DRUG
    Acalabrutinib will be administered orally

Study Details

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies

Key Dates

Start date
Jan 30, 2025
Status verified
Jun 2026
Primary completion
Feb 28, 2028
Completion
Jun 11, 2029

Study Design

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

Arms

  • Experimental: Substudy 1 (RR CLL/SLL): Cohort 1A (Surovatamig Monotherapy)
    Participants will receive surovatamig monotherapy as subcutaneous (SC) injection.
  • Experimental: Substudy 1 (RR CLL/SLL): Cohort 1B (Surovatamig + Acalabrutinib)
    Participants will receive surovatamig as SC injection. Participants will receive acalabrutinib tablet orally twice daily.
  • Experimental: Substudy 1 (RR CLL/SLL): Cohort 1C (Surovatamig Monotherapy)
    Participants will receive surovatamig monotherapy as intravenous (IV) infusion.
  • Experimental: Substudy 2 (RR MCL): Cohort 2A (Surovatamig Monotherapy)
    Participants will receive surovatamig monotherapy as SC injection.
  • Experimental: Substudy 2 (RR MCL): Cohort 2C (Surovatamig Monotherapy)
    Participants will receive surovatamig monotherapy as IV infusion.
  • Experimental: Substudy 3 (LBCL): Cohort 3A 2SUD (Surovatamig + RCHOP)
    Participants will receive surovatamig as IV infusion with a 2SUD (double step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.
  • Experimental: Substudy 3 (LBCL): Cohort 3B 3SUD (Surovatamig + RCHOP)
    Participants will receive surovatamig as IV infusion with a 3SUD (triple step-up dosing) schedule for priming in combination with RCHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy.

Primary Outcome Measure

Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest [ Time Frame: Up to 6 years 4 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
Research SiteBostonMassachusetts02215-
Research SiteHackensackNew Jersey07601-
Research SiteNew BrunswickNew Jersey08901-
Research SiteNew YorkNew York10029-
Research SiteNew YorkNew York10065-
Research SiteCharlotteNorth Carolina28204-
Research SiteCharlotteNorth Carolina28204-
Research SiteColumbusOhio43210-
Research SitePortlandOregon97239-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15232-
Research SiteProvidenceRhode Island02903-
Research SiteHoustonTexas77030-

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