AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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| Research Site | Birmingham | Alabama | Withdrawn |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| Research Site | Seattle | Washington | Withdrawn |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| Research Site | Melbourne | Australia | Withdrawn |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.
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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.
View NCT06137118 on ClinicalTrials.gov ↗ ← All trials in South Korea