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

NCT06526793 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: D7404C000012023-505789-27-00
• Study Type: interventional
• Target: 240
• Locations: 16 countries
• Sites: 94

Brief Summary

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.

Conditions

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

Keywords

AZD0486; Surovatamig; Follicular Lymphoma (FL); Large B-Cell Lymphoma (LBCL); Non-Hodgkin lymphoma (NHL); Relapsed/Refractory

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) (central review)

  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

  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 (23)

• Incidence, nature and severity of Adverse Events (AEs), Serious AEs and AEs of Special Interest (AESI)

  From time of Informed Consent to 90-day safety follow-up visit

• Incidence and nature of study drug discontinuation, dose reduction, and dose delay due to Adverse Events (AEs)

  From the start of treatment up to 2 years in Module 1 and up to 1 year for Module 2

• Duration of response (DoR)

  To be assessed up to approximately 5 years.

• Complete response (CR) rate (central review)

  To be assessed up through study completion, up to approximately 5 years

• Complete response (CR) rate (investigator assessment)

  To be assessed up through study completion, up to approximately 5 years

Study Arms (2)

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

EXPERIMENTAL

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.

Drug: Surovatamig

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

EXPERIMENTAL

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.

Drug: Surovatamig

Interventions

Surovatamig DRUG

Investigational Product administered via intravenous infusion.

Also known as: AZD0486

Module 1: Surovatamig Monotherapy in Participants with Relapsed or Refractory Follicular Lymphoma; Module 2: Surovatamig Monotherapy in Participants with Relapsed or Refractory LBCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ,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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (94)

Research Site

Phoenix, Arizona, 85054, United States

NOT YET RECRUITING

Research Site

Duarte, California, 91010, United States

RECRUITING

Research Site

Jacksonville, Florida, 32224, United States

NOT YET RECRUITING

Research Site

Tampa, Florida, 33612, United States

RECRUITING

Research Site

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

Research Site

Iowa City, Iowa, 52242, United States

NOT YET RECRUITING

Research Site

Waukee, Iowa, 50263, United States

RECRUITING

Research Site

Overland Park, Kansas, 66204, United States

WITHDRAWN

Research Site

Rochester, Minnesota, 55905, United States

RECRUITING

Research Site

St Louis, Missouri, 63110, United States

WITHDRAWN

Research Site

New Brunswick, New Jersey, 08901, United States

WITHDRAWN

Research Site

New York, New York, 10016, United States

RECRUITING

Research Site

Charlotte, North Carolina, 28204, United States

RECRUITING

Research Site

Columbus, Ohio, 43210, United States

RECRUITING

Research Site

Portland, Oregon, 97239, United States

RECRUITING

Research Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Research Site

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Research Site

Pittsburgh, Pennsylvania, 15232, United States

WITHDRAWN

Research Site

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Research Site

Austin, Texas, 78704, United States

NOT YET RECRUITING

Research Site

Houston, Texas, 77030, United States

RECRUITING

Research Site

San Antonio, Texas, 78229, United States

NOT YET RECRUITING

Research Site

Milwaukee, Wisconsin, 53226, United States

RECRUITING

Research Site

Heidelberg, 3084, Australia

RECRUITING

Research Site

Kogarah, NSW 2217, Australia

RECRUITING

Research Site

Macquarie University, 2109, Australia

RECRUITING

Research Site

Nedlands, 6009, Australia

RECRUITING

Research Site

Porto Alegre, 90035903, Brazil

SUSPENDED

Research Site

São Paulo, 01401-002, Brazil

RECRUITING

Research Site

São Paulo, 05652-900, Brazil

RECRUITING

Research Site

Barrie, Ontario, L4M 6M2, Canada

NOT YET RECRUITING

Research Site

Brampton, Ontario, L6R 3J7, Canada

RECRUITING

Research Site

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

Research Site

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Research Site

Chengdu, 610041, China

RECRUITING

Research Site

Chengdu, 610072, China

RECRUITING

Research Site

Guangzhou, 510060, China

RECRUITING

Research Site

Nanchang, 330029, China

RECRUITING

Research Site

Nanjing, 210029, China

RECRUITING

Research Site

Nantong, 226001, China

RECRUITING

Research Site

Shandong, China

RECRUITING

Research Site

Shanghai, 200025, China

NOT YET RECRUITING

Research Site

Shanghai, 200032, China

RECRUITING

Research Site

Tianjin, 300020, China

RECRUITING

Research Site

Zhengzhou, 450008, China

RECRUITING

Research Site

Aalborg, 9100, Denmark

WITHDRAWN

Research Site

Copenhagen, 2100, Denmark

RECRUITING

Research Site

Vejle, 7100, Denmark

RECRUITING

Research Site

Montpellier, 34295, France

RECRUITING

Research Site

Paris, 75010, France

RECRUITING

Research Site

Pierre-Bénite, 69495, France

RECRUITING

Research Site

Rouen, 76038, France

RECRUITING

Research Site

Berlin, 10967, Germany

RECRUITING

Research Site

Chemnitz, 9116, Germany

NOT YET RECRUITING

Research Site

Essen, 45147, Germany

NOT YET RECRUITING

Research Site

Jena, 07747, Germany

RECRUITING

Research Site

Würzburg, 97080, Germany

RECRUITING

Research Site

Hong Kong, 999077, Hong Kong

RECRUITING

Research Site

Shatin, 00000, Hong Kong

NOT YET RECRUITING

Research Site

Alessandria, 15121, Italy

RECRUITING

Research Site

Bologna, 40138, Italy

RECRUITING

Research Site

Busto Arsizio, 21052, Italy

RECRUITING

Research Site

Milan, 20132, Italy

RECRUITING

Research Site

Milan, 20141, Italy

RECRUITING

Research Site

Roma, 161, Italy

NOT YET RECRUITING

Research Site

Chiba, 260-8717, Japan

RECRUITING

Research Site

Kashiwa, 277-8577, Japan

RECRUITING

Research Site

Kōtoku, 135-8550, Japan

RECRUITING

Research Site

Kumamoto, 860-0008, Japan

RECRUITING

Research Site

Niigata, 951-8520, Japan

RECRUITING

Research Site

Okayama, 700-8558, Japan

RECRUITING

Research Site

Osaka, 541-8567, Japan

RECRUITING

Research Site

Yokohama, 241-8515, Japan

RECRUITING

Research Site

Seoul, 03080, South Korea

RECRUITING

Research Site

Seoul, 06351, South Korea

RECRUITING

Research Site

Seoul, 06591, South Korea

RECRUITING

Research Site

Seoul, 3722, South Korea

RECRUITING

Research Site

Seoul, 5505, South Korea

RECRUITING

Research Site

Barcelona, 08035, Spain

RECRUITING

Research Site

Madrid, 28040, Spain

RECRUITING

Research Site

Pozuelo de Alarcón, 28223, Spain

RECRUITING

Research Site

Gothenburg, 41345, Sweden

RECRUITING

Research Site

Stockholm, 17176, Sweden

RECRUITING

Research Site

Kaohsiung City, 80756, Taiwan

WITHDRAWN

Research Site

Kaohsiung City, 833401, Taiwan

RECRUITING

Research Site

Taichung, 404, Taiwan

RECRUITING

Research Site

Taichung, 40705, Taiwan

RECRUITING

Research Site

Tainan, 70403, Taiwan

RECRUITING

Research Site

Taipei, 106, Taiwan

RECRUITING

Research Site

London, SE5 9RS, United Kingdom

RECRUITING

Research Site

Manchester, M20 4BX, United Kingdom

RECRUITING

Research Site

Norwich, NR4 7UY, United Kingdom

RECRUITING

Research Site

Nottingham, NG5 1PB, United Kingdom

RECRUITING

Research Site

Plymouth, PL6 8DH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Recurrence

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The trial will assess surovatamig (AZD0486) monotherapy given by IV infusion. Module 1 will evaluate the efficacy and safety of surovatamig monotherapy at the recommended Phase 2 dose (RP2D), in participants 18 years of age or older , with relapsed or refractory (R/R) follicular lymphoma (FL) who have received ≥ 2 prior therapies. Module 2 will evaluate the efficacy and safety of surovatamig monotherapy at the RP2D for participants 18 years of age or older with (R/R) large B-cell lymphoma (LBCL) who have received ≥ 2 prior therapies.

Study Record Dates

• First Submitted: July 3, 2024
• First Posted: July 30, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): June 14, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements: thttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

DK (3); DE (5); ES (3); AU (4); FR (4); TW (6); IT (6); SE (2); BR (3); CA (4); KR (5); HK (2); JP (8); CN (11); GB (5); US (23)