Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0CWADI
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| ADC Name |
Tilatamig samrotecan
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| Synonyms |
tilatamig samrotecan; AZD9592; tila-sam
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| Organization |
AstraZeneca (Top20 MNC) (Originator)
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| Drug Status |
Phase 2
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| Drug-to-Antibody Ratio |
6
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| Structure |
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| Antibody Name |
Tilatamig
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Antibody Info | ||||
| Antigen Name |
Hepatocyte growth factor receptor (MET); Epidermal growth factor receptor (EGFR)
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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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| Colorectal cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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| Lung cancer |
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 |
Eligible patients (≥18 years, ECOG 0-1) require measurable disease (RECIST v1.1), adequate organ function, and module-specific histology confirmation (EGFRmut NSCLC/HNSCC/CRC). Key exclusions include active ILD, untreated CNS metastases, uncontrolled infections, or significant cardiac comorbidities.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05647122 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints include AE/SAE incidence (monitored from consent to 30 days post-treatment), DLT assessment during first 21 days, lab/ECG/vital sign changes, and ORR (RECIST v1.1) in expansion cohorts over ~2 years.
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| Other Endpoint |
Secondary endpoints comprise efficacy measures (ORR/DOR/DCR/PFS/OS) assessed via RECIST v1.1 over ~2 years, comprehensive PK analysis (AUC/Cmax/Tmax/clearance/half-life), and ADA immunogenicity evaluation until 30 days post-treatment.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-2) require confirmed HNSCC (oropharynx/hypopharynx/oral cavity/larynx) with injectable lesions meeting viability criteria. Key exclusions: insufficient tumor volume, critical structure proximity, prior immune/ADC therapy (last 5 years), pregnancy/lactation, uncontrolled comorbidities, or recent major surgery (<4 weeks). Contraception required for 7 months post-procedure.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06366451 | Clinical Status | EARLY_PHASE1 | ||
| Clinical Description | A Phase 0 Multicenter Study of the Pharmacodynamic Effects of Intratumoral Microdose Administration of Rilvegostomig, Volrustomig, Sabestomig, and AZD9592 | ||||
| Primary Endpoint |
The primary objective involves spatial transcriptomic analysis (NanoString GeoMx DSP) of tumor microenvironments 1-3 days post-microdose injection of rilvegostomig, volrustomig, sabestomig, AZD9592, or pembrolizumab (mono/combination therapy), evaluating 1800+ genes with potential IHC/ISH validation.
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| Other Endpoint |
Safety monitoring includes AE/ADE assessment (frequency, severity, causality) for 28 days post-microdose procedure in HNSCC patients with surgically accessible lesions (primary/recurrent/metastatic).
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Patients with metastatic non-small cell lung cancer (mNSCLC) with EGFRm (sensitizing L858R mutation or exon 19 deletions) or EGFR wild-type, or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC).
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05647122 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1, multicenter, open-label, first-in-human, dose escalation and expansion study of AZD9592 as monotherapy and in combination with anti-cancer agents in patients with advanced solid tumors. | ||||
References