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

AstraZeneca

Status and phase: Enrolling; Phase 2

Conditions: Large B-Cell Lymphoma (LBCL); B-cell Non-Hodgkin Lymphoma; Follicular Lymphoma (FL)

Treatments: Drug: Surovatamig

Study type: Interventional

Funder types: Industry

Identifiers

NCT06526793

D7404C00001

2023-505789-27-00 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

This is a modular, Phase II, multicenter, single-arm, open-label study to evaluate the efficacy and safety of Surovatamig (AZD0486) monotherapy administered as an intravenous (IV) infusion in participants with relapsed or refractory B-NHL. The purpose of this study is to determine the efficacy and safety of AZD0486 administered at the RP2D in adults 18 years of age or older with relapsed or refractory B-NHL.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Key Inclusion Criteria:

   • 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

   • FDG-avid disease with at least one bi-dimensionally measurable nodal lesion (defined as > 1.5 cm in its longest dimension), or extranodal lesion (defined as > 1.0 cm in its longest dimension)

   • Adequate hematological function: ANC ≥ 1000/mm3, platelets

     • 75,000/mm3, hemoglobin ≥ 9 g/dL. Transfusion and/or growth factor are allowed but counts must be stable for at least 72 hours afterwards prior to screening

   • Adequate liver function: total bilirubin <1.5x ULN, AST/ALT ≤ 3xULN or < 5 × ULN in the presence of lymphoma involvement of the liver

   • Adequate renal function: creatinine clearance (CrCl) of ≥ 45 mL/min

   • Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 45% by echocardiogram or MUGA

   The above is a summary, other inclusion criteria details may apply.

2. Key Exclusion Criteria:

   • Diagnosis of CLL, Burkitt lymphoma, or Richter's transformation
   • Active CNS involvement by B-NHL
   • Leukemic presentation of B-NHL
   • History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, neurodegenerative disorder including Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis or other severe mental illness
   • Prior therapy with T-cell engager (TCE) within 8 weeks, autologous Hematopoietic Stem Cell Transplantation (HSCT) within 12 weeks, CAR T- cell therapy within 6 months, or prior allogeneic HSCT within 24 weeks of first dose of surovatamig
   • Requires chronic immunosuppressive therapy
   • Unresolved non hematological AEs ≥ Grade 2 from prior therapies; history of ≥ Grade 3 CRS or neurotoxicity from prior CAR-T or TCE therapy
   • History of major cardiac abnormalities.
   • If female, participant must not be pregnant or breastfeeding.

The above is a summary, other exclusion criteria details may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma

Experimental group

Description:

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.

Treatment:

Drug: Surovatamig

Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL

Experimental group

Description:

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.

Treatment:

Drug: Surovatamig