Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0JXUXU
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| ADC Name |
Lixarkitug samrotecan
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| Synonyms |
AZD9829
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| Organization |
AstraZeneca (Top20 MNC) (Originator)
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| Drug Status |
Phase 1/2 (discontinued)
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| Drug-to-Antibody Ratio |
8
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| Structure |
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| Antibody Name |
INT016
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Antibody Info | ||||
| Antigen Name |
Interleukin-3 receptor subunit alpha (IL3RA)
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Antigen Info | ||||
| Payload Name |
AZ14170132 (AZ0132)
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mal-PEG8-Val-Ala
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
samrotecan
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Acute myeloid leukaemia |
1 Trials
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| Myelodysplastic syndrome |
1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key eligibility: Adults (≥18) with CD123+ R/R AML or HR-MDS (≥5% blasts) after ≥1 prior therapy, ECOG ≤2. Major exclusions: CNS leukemia, prior CD123-targeted therapy, recent HSCT/cell therapy (90/60 days), active GVHD requiring immunosuppression, uncontrolled infections, or unresolved Grade ≥2 AEs from prior treatments.
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| Administration Dosage |
AZD9829 will be administered by IV infusion
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| Related Clinical Trial | |||||
| NCT Number | NCT06179511 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | 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 | ||||
| Primary Endpoint |
Primary endpoints include DLT frequency assessment (28-day observation) and comprehensive safety evaluation (CTCAE v4.0) of AZD9829 in R/R AML patients, monitoring AEs/SAEs from consent until 60 days post-treatment to determine RP2D based on safety and PK profiles.
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| Other Endpoint |
Secondary objectives comprise detailed PK analysis (plasma concentrations, AUC, Cmax, tmax, clearance, t1/2) and immunogenicity (ADA incidence) measured up to 30 days post-dose, along with efficacy outcomes (ORR, CCRR, CR/CRi per ELN2022/IWG criteria, DoR, TTR, TTNT, PFS, OS, EFS) assessed over 1 year.
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