Antibody Information
General Information of This Antibody
| Antibody ID | ANI0WCKSM |
|||||
|---|---|---|---|---|---|---|
| Antibody Name | INT016 |
|||||
| Antibody Type | Monoclonal antibody (mAb) |
|||||
| Antibody Subtype | Humanized IgG |
|||||
| Antigen Name | V-set domain-containing T-cell activation inhibitor 1 (VTCN1) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Lixarkitug samrotecan [Phase 1/2 (discontinued)]
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.
|
||||
| Administration Dosage |
AZD9829 will be administered by IV infusion
|
||||
| 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.
|
||||
| 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.
|
||||