A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
Soundtrack-E
A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies
2 other identifiers
interventional
408
13 countries
64
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2025
Longer than P75 for phase_1
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2024
CompletedFirst Posted
Study publicly available on registry
August 21, 2024
CompletedStudy Start
First participant enrolled
January 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 11, 2029
June 10, 2026
June 1, 2026
3.1 years
August 19, 2024
June 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Up to 6 years 4 months
Number of Participants with Dose Limiting Toxicity (DLTs)
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Up to 2 months
Secondary Outcomes (11)
Overall Response Rate (ORR)
Up to 6 years 4 months
Complete Response (CR) Rate
Up to 6 years 4 months
Duration of Response (DoR)
Up to 6 years 4 months
Maximum Observed Concentration (Cmax)
Up to 90 days after last dose
Area Under the Concentration-time Curve (AUC)
Up to 90 days after last dose
- +6 more secondary outcomes
Study Arms (7)
Substudy 1 (RR CLL/SLL): Cohort 1A (Surovatamig Monotherapy)
EXPERIMENTALParticipants will receive surovatamig monotherapy as subcutaneous (SC) injection.
Substudy 1 (RR CLL/SLL): Cohort 1B (Surovatamig + Acalabrutinib)
EXPERIMENTALParticipants will receive surovatamig as SC injection. Participants will receive acalabrutinib tablet orally twice daily.
Substudy 1 (RR CLL/SLL): Cohort 1C (Surovatamig Monotherapy)
EXPERIMENTALParticipants will receive surovatamig monotherapy as intravenous (IV) infusion.
Substudy 2 (RR MCL): Cohort 2A (Surovatamig Monotherapy)
EXPERIMENTALParticipants will receive surovatamig monotherapy as SC injection.
Substudy 2 (RR MCL): Cohort 2C (Surovatamig Monotherapy)
EXPERIMENTALParticipants will receive surovatamig monotherapy as IV infusion.
Substudy 3 (LBCL): Cohort 3A 2SUD (Surovatamig + RCHOP)
EXPERIMENTALParticipants 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.
Substudy 3 (LBCL): Cohort 3B 3SUD (Surovatamig + RCHOP)
EXPERIMENTALParticipants 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.
Interventions
Surovatamig will be administered as either SC injection or IV infusion.
Vincristine will be administered as IV infusion as per standard of care.
Doxorubicin will be administered as IV infusion as per standard of care.
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
Rituximab will be administered as IV infusion as per standard of care.
Cyclophosphamide will be administered as IV infusion as per standard of care.
Acalabrutinib will be administered orally
Eligibility Criteria
You may qualify if:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Contraception use during treatment and at least 90 days after final dose.
- Confirmed CD19 expression if prior anti-CD19 therapy.
- Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
- SLL: at least 1 measurable site per Lugano.
- Absolute lymphocyte count (ALC) \<25000 cells/mcL.
- Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
- Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.
- MCL diagnosis per WHO.
- Clinical Stage II, III, or IV by Ann Arbor Classification.
- At least 1 measurable site per Lugano.
- ALC \< 25000 cells/mcL.
- Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
- At least 1 measurable site as per Lugano.
- Left ventricular ejection fraction (LVEF) ≥50%.
- +9 more criteria
You may not qualify if:
- Central nervous system (CNS) lymphoma.
- Surgery within 14 days of study drug.
- Clinically significant cardiovascular (CV) disease.
- Unresolved Grade \>2 AEs from prior anticancer therapy (except alopecia or fatigue).
- Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
- Radiation therapy within 28 days.
- Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
- Prior Grade \> 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
- Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
- Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).
- CLL/SLL transformation to more aggressive form of lymphoma.
- Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.
- Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
- Cumulative dose of anthracycline \>150 mg/m2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (64)
Research Site
Boston, Massachusetts, 02215, United States
Research Site
Hackensack, New Jersey, 07601, United States
Research Site
New Brunswick, New Jersey, 08901, United States
Research Site
New York, New York, 10029, United States
Research Site
New York, New York, 10065, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Charlotte, North Carolina, 28204, United States
Research Site
Columbus, Ohio, 43210, United States
Research Site
Portland, Oregon, 97239, United States
Research Site
Philadelphia, Pennsylvania, 19104, United States
Research Site
Pittsburgh, Pennsylvania, 15232, United States
Research Site
Providence, Rhode Island, 02903, United States
Research Site
Houston, Texas, 77030, United States
Research Site
Heidelberg, 3084, Australia
Research Site
Melbourne, 3004, Australia
Research Site
Nedlands, 6009, Australia
Research Site
Beijing, 100044, China
Research Site
Guangzhou, 510060, China
Research Site
Jinan, 250013, China
Research Site
Tianjin, 300060, China
Research Site
Zhengzhou, 450008, China
Research Site
Ostrava - Poruba, 708 52, Czechia
Research Site
Prague, 12808, Czechia
Research Site
Praha 2 - Nové Město, 12820, Czechia
Research Site
Aalborg, 9000, Denmark
Research Site
Aarhus N, 8200, Denmark
Research Site
Copenhagen, 2100, Denmark
Research Site
Odense C, 5000, Denmark
Research Site
Clermont-Ferrand, 63000, France
Research Site
Montpellier, 34295, France
Research Site
Paris, 75010, France
Research Site
Saint-Cloud, 92210, France
Research Site
Villejuif, 94805, France
Research Site
Cologne, 50937, Germany
Research Site
Homburg, 66421, Germany
Research Site
Kiel, 24105, Germany
Research Site
Mainz, 55131, Germany
Research Site
München, 81377, Germany
Research Site
Würzburg, 97080, Germany
Research Site
Bologna, 40138, Italy
Research Site
Milan, 20141, Italy
Research Site
Kōtoku, 135-8550, Japan
Research Site
Matsuyama, 791-0280, Japan
Research Site
Nagoya, 464-8681, Japan
Research Site
Busan, 48108, South Korea
Research Site
Seoul, 02841, South Korea
Research Site
Seoul, 03080, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Barcelona, 8036, Spain
Research Site
Madrid, 28034, Spain
Research Site
Madrid, 28040, Spain
Research Site
Palma de Mallorca, 7120, Spain
Research Site
Santiago de Compostela, 15706, Spain
Research Site
Valencia, 46026, Spain
Research Site
Changhua, 500, Taiwan
Research Site
Kaohsiung City, 83301, Taiwan
Research Site
Tainan, 710, Taiwan
Research Site
Taipei, 100, Taiwan
Research Site
Derriford, PL6 5FP, United Kingdom
Research Site
London, SE5 9RS, United Kingdom
Research Site
Oxford, 0X3 7LJ, United Kingdom
Research Site
Southampton, SO16 6YD, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2024
First Posted
August 21, 2024
Study Start
January 30, 2025
Primary Completion (Estimated)
February 28, 2028
Study Completion (Estimated)
June 11, 2029
Last Updated
June 10, 2026
Record last verified: 2026-06
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/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via there quest portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure."Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.