Antibody Information
General Information of This Antibody
| Antibody ID | ANI0QYT014 |
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| Antibody Name | Puxitatug |
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| Organization | AstraZeneca PLC; BSP Pharmaceuticals SpA |
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| Synonyms |
Puxitatug
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antigen Name | V-set domain-containing T-cell activation inhibitor 1 (VTCN1) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
QVQLQQWGAGLLKPSETLSLACTVYGGSFSGYYWNWIRQPPGKGLEWIGEINHSGSTSYN
PSLKSRVTISVDTSKNQFSLKLSSVTAADTAVYYCARVLYNWNVDSWGQGTLVTVSS Click to Show/Hide
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| Light Chain Sequence |
DIQMTQSPSSLSASVGDRVTITCRASQDIRNDVGWYQQKPGKAPKRLIYAASRLQSGVPS
RFSGSGSGTEFTLTISSLQPEDFATYYCLQHNSYPRTFGQGTKVEIK Click to Show/Hide
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Each Antibody-drug Conjugate Related to This Antibody
Full Information of The Activity Data of The ADC(s) Related to This Antibody
Puxitatug samrotecan [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
69%
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| Patients Enrolled |
Eligible patients (≥18 years) must have relapsed/metastatic solid tumors, measurable disease (RECIST 1.1), ECOG 0-1, and adequate organ function. Exclusions: active infections (HBV/HCV/HIV), untreated brain metastases, symptomatic cardiac disease (QTc >470 ms, heart failure, arrhythmias), recent anticancer therapy (<21 days for cytotoxic agents), or ILD. Sub-study-specific exclusions apply (e.g., autoimmune disorders for rilvegostomig combinations, CYP3A4 modifiers for saruparib).
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| Administration Dosage |
Single administration of 3.5 mg/kg AZD8205.
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| Related Clinical Trial | |||||
| NCT Number | NCT05123482 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase I/IIa Multi-center, Open-label Master Protocol Dose Escalation and Expansion Study of AZD8205 as Monotherapy and in Combination With Anticancer Agents in Participants With Advanced Solid Tumors (BLUESTAR)
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| Primary Endpoint |
The study monitors safety parameters including adverse events (AEs), serious adverse events (SAEs), dose-limiting toxicities (DLTs), and changes in lab values/ECGs/vital signs during treatment and up to 30 days post-dose. DLTs are assessed in Cycle 1 (21 days) per protocol-defined criteria.
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| Other Endpoint |
Efficacy is evaluated via RECIST 1.1, measuring objective response rate (ORR), duration of response (DoR), progression-free survival (PFS), disease control rate at 12 weeks (DCR-12), and overall survival (OS). Pharmacokinetics (AUC, Cmax, Tmax, clearance, t1/2) and immunogenicity (ADA development) are assessed for AZD8205 alone or combined with rilvegostomig/saruparib. Intratumoral biomarkers (gamma H2AX) are analyzed in sub-studies.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Patients 18 years old with cholangiocarcinoma, breast, ovarian or endometrial cancers and ECOG PS 0-1.
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| Related Clinical Trial | |||||
| NCT Number | NCT05123482 | Clinical Status | Phase 1/2 | ||
| Clinical Description |
A phase 1/2a multi-center, open-label master protocol to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of AZD8205 in participants with advanced or metastatic solid malignancies.
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Discovered Using Patient-derived Xenograft Model
| Experiment 1 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
69%
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Positive VTCN1 expression (VTCN1+++/++) | ||
| Method Description |
In the study of 26 PDX tumors,single administration of 3.5 mg/kg AZD8205 to determine the ORR,according to modified RECIST criteria,which correlated with homologous recombination repair (HRR) deficiency (HRD) and elevated levels of B7-H4 in HRR-proficient models.
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| In Vivo Model | Multiple tumor PDX model | ||||
References