NCT06179511已完成1 期
A Modular Phase I/II, Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of AZD9829 as Monotherapy or in Combination in Patients With CD123-Positive Hematological Malignancies
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 56
- 试验地点
- 22
- 主要终点
- Frequency of dose limiting toxicities (DLTs).
研究概览
简要总结
This is a modular, multicentre, open-label, Phase I/II, dose-setting study. AZD9829 will be administered intravenously as monotherapy or in combination in participants with CD123 positive hematological malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age;
- •CD123+ hematologic malignancy based on flow cytometry or immunohistochemistry by local laboratory;
- •R/R AML (except APL);
- •R/R HR-MDS with ≥5% bone marrow blast at time of inclusion;
- •Had at least 1 prior line of therapy at currents histology, and have no available treatment options;
- •ECOG performance status of ≤
- •The above is a summary, other inclusion criteria details may apply.
排除标准
- •Active CNS leukemia;
- •Previous treatment with any CD123 targeting therapy;
- •Prior allogeneic HSCT, within 90 or cell therapy within 60 of start of therapy;
- •Active GVHD that requires immunosuppressive treatment within 4 weeks prior to start of AZD9829;
- •History of other malignancy(with certain exceptions);
- •Active and uncontrolled infections;
- •Unresolved AEs ≥2 Grade, from prior therapies.
- •The above is a summary, other exclusion criteria details may apply .
研究组 & 干预措施
Module 1: Dose Escalation
Experimental
Ascending dose level cohorts of AZD9829 in AML and MDS participants.
干预措施: AZD9829 (Drug)
Module 1: Dose Optimization
Experimental
Characterizing the safety, tolerability, PK/PD, and preliminary antitumor activity of AZD9829 in CD123+ R/R AML participants, based on the data collected during dose escalation, dose optimization and backfill.
干预措施: AZD9829 (Drug)
结局指标
主要结局
Frequency of dose limiting toxicities (DLTs).
时间窗: Module 1 - 28 days.
DLTs are dose-limiting toxicities as defined in the study protocol.
Safety evaluation of AZD9829: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
时间窗: Module 1 - From informed consent until 60 days after last dose of AZD9829.
Frequency, severity and relationship to study drug of AEs and SAEs
Identify RP2D in R/R AML patients.
时间窗: Moldule 1 -From informed consent until 60 days after last dose of AZD9829.
Incidence of AEs/SAEs and PK data
次要结局
- Pharmacokinetics of AZD9829: Plasma Concentration of total antibody(Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.)
- Pharmacokinetics of AZD9829: Plasma Concentration of total unconjugated warhead(Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.)
- Pharmacokinetics of AZD9829: Area under the concentration time curve (AUC).(Module 1 - From date of first dose of AZD9829up until 30 days post last dose.)
- Pharmacokinetics of AZD9829: Maximum plasma concentration of the study drug (Cmax).(Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.)
- Pharmacokinetics of AZD9829: Time to maximum concentration (tmax)(Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.)
- Pharmacokinetics of AZD9829: Clearance(Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.)
- Pharmacokinetics of AZD9829: Half-life (t 1/2)(Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.)
- Overall Response Rate (ORR)(Module 1 - From first dose of AZD9829 until disease progression or end of the study (upto approximately 1 year))
- Composite Complete Response Rate (CCRR)(Module 1 - From first dose of AZD9829 up to approximately 1 year.)
- Complete remission with incomplete hematologic recovery (CRi)(Module 1 - From first dose of AZD9829 up to approximately 1 year.)
- Complete Response (CR)(Module 1 - From first dose of AZD9829 up to approximately 1 year.)
- Duration of Response (DoR)(Module 1 -Time from first documented response until disease progression or death (approximately 1 year).)
- Time to Response (TTR)(Module 1 - From first dose of AZD9829 until complete remission, disease progression or death (approximately 1 year).)
- Time to Next Treatment (TTNT)(Module 1 - From first dose of AZD9829 until the date of subsequent anti-leukemia-therapy or death (approximately 1 year).)
- Progression-free Survival (PFS)(Module 1 - From first dose of AZD9829 until disease progression or death (approximately 1 year).)
- Overall Survival (OS)(Module 1 - From first dose of AZD9829 until death (approximately 1 year).)
- Event-free Survival (EFS)(Module 1 - From first dose of AZD9829 until disease progression, death, or initiation of a new anti-leukemic therapy (approximately 1 year).)
- Pharmacokinetics of AZD9829: Anti-Drug Antibodies (ADA)(Module 1 - From date of first dose of AZD9829 up until 30 days post last dose.)
- To determine the immunogenicity of AZD9829.(Module 1 - From first dose to the 30-Day SFU visit)
研究者
研究点 (22)
Loading locations...
相似试验
已完成
1 期
AZD4573 in Novel Combinations With Anti-cancer Agents in Patients With Advanced Blood CancerAdvanced Haematological MalignanciesNCT04630756AstraZeneca40
已完成
1 期
A Clinical Trial to Evaluate AZD7648 Alone and in Combination With Other Anti-cancer Agents in Patients With Advanced Cancers.Advanced MalignanciesNCT03907969AstraZeneca30
招募中
1 期
AZD0305 as Monotherapy or in Combination With Anticancer Agents in Participants With Multiple MyelomaMultiple MyelomaNCT06106945AstraZeneca226
已完成
1 期
Evaluate Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of AZD3759Non Small Cell Lung CancerNCT03360929LYZZ Alpha Holding Ltd15
招募中
1 期
A Clinical Trial of LBL-034 in Patients With Relapsed Refractory Multiple MyelomaRelapsed/Refractory Multiple MyelomaNCT06049290Nanjing Leads Biolabs Co.,Ltd342