Surovatamig: Investigational Product administered via intravenous infusion.
Study summary
This is a Phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimization study of surovatamig (AZD0486) to evaluate the safety, tolerability, and efficacy of surovatamig (AZD0486) monotherapy in participants with R/R B ALL. The study will consist of 4 parts. Part A: monotherapy dose escalation in 3L+ B-ALL. Part B: dose optimization in 3L+ B-ALL. Part C: Dose expansion in 3L+ B-ALL. Part D: Dose optimization and efficacy expansion in R/R B-ALL (2L+)
Eligibility
Sex
ALL
Min age
12 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Age: 12 years and above (Parts A, B, C and D).
* Participants with B-cell Acute Lymphoblastic Leukemia with CD19 expression by local lab with:
1. Bone marrow infiltration with \>/= 5% blasts
2. Either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no SOC available option (Parts A, B, C); or relapsed or refractory to ≥1 prior line of therapy (Part D).
3. Philadelphia positive participants are allowed in all parts of the study, if intolerant or refractory to TKIs.
* For participants older than 16 years, Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2. For Participants 16 years or younger, Lansky score more or equal to 50%.
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria:
* Active CNS involvement by B-ALL, defined by presence of ALL blasts in CSF (CNS2 and CNS3 criteria), or signs of CNS involvement.
* Isolated extramedullary disease relapse.
* Testicular leukemia
* History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior Grade 4 neurotoxicity with CAR-T or TCE therapy.
* History of other malignancy (with certain exceptions).
* Unresolved AEs \>/= Grade 2, from prior therapies
* Prior therapy with ADCs within 3 weeks, TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks or prior alloSCT within 12 weeks of start of therapy.
* GVHD requiring immunosuppressive therapy within 3 weeks prior to AZD0486 treatment.
The above is a summary, other exclusion criteria details may apply.
Primary outcome measure(s)
Part A: Frequency of DLTs — Up to 28 days DLTs are dose-limiting toxicities as defined in the study protocol
Parts A & B: Safety Evaluation of AZD0486 — From signing of informed consent through data cutoff, up to 57 months Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in laboratory evaluations; QTc, and vital signs changes.
Parts B & C: Rate of CR within 3 cycles — Up to three cycles of 28 days each To evaluate the efficacy of surovatamig based on NCCN response criteria (in Part B and C).
Part D: CR/CRh within 3 cycles — Up to three cycles of 28 days each To evaluate the efficacy of surovatamig in Part D based on NCCN response criteria. CR/CRh is defined as a best response of CR/CRh within 3 cycles.
Trial sites (82)
Facility
City
Region
Status
Research Site
Birmingham
Alabama
Withdrawn
Research Site
Duarte
California
Recruiting
Research Site
Los Angeles
California
Recruiting
Research Site
Palo Alto
California
Recruiting
Research Site
Tampa
Florida
Recruiting
Research Site
Atlanta
Georgia
Recruiting
Research Site
Chicago
Illinois
Recruiting
Research Site
New York
New York
Recruiting
Research Site
Houston
Texas
Recruiting
Research Site
Richmond
Virginia
Recruiting
Research Site
Seattle
Washington
Withdrawn
Research Site
Milwaukee
Wisconsin
Recruiting
Research Site
Melbourne
Australia
Withdrawn
Research Site
Porto Alegre
Brazil
Suspended
Research Site
São Paulo
Brazil
Suspended
Research Site
São Paulo
Brazil
Suspended
Research Site
Toronto
Ontario
Suspended
Research Site
Montreal
Quebec
Withdrawn
Research Site
Montreal
Quebec
Withdrawn
Research Site
Changsha
China
Recruiting
Research Site
Chengdu
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Guangzhou
China
Recruiting
Research Site
Hangzhou
China
Recruiting
Research Site
Nanjing
China
Recruiting
Research Site
Nanjing
China
Recruiting
Research Site
Suzhou
China
Recruiting
Research Site
Tianjin
China
Recruiting
Research Site
Zhengzhou
China
Recruiting
Research Site
Caen
France
Suspended
Research Site
Marseille
France
Suspended
Research Site
Nantes
France
Suspended
Research Site
Paris
France
Suspended
Research Site
Pierre-Bénite
France
Suspended
Research Site
Toulouse
France
Suspended
Research Site
Berlin
Germany
Not Yet Recruiting
Research Site
Cologne
Germany
Suspended
Research Site
Düsseldorf
Germany
Suspended
Research Site
Essen
Germany
Withdrawn
Research Site
Frankfurt
Germany
Suspended
+ 42 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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