Antibody Information
General Information of This Antibody
| Antibody ID | ANI0QYT006 |
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| Antibody Name | Sonesitatug |
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| Organization | Keymed Biosciences, Inc.; Shanghai Miracogen Inc.; Lepu Biopharma Co., Ltd.; AstraZeneca PLC |
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| Synonyms |
Sonesitatug
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| Antibody Type | Monoclonal antibody (mAb) |
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| Antigen Name | Claudin-18.2 (CLDN18.2) |
Antigen Info | ||||
| Click to Show/Hide the Sequence Information of This Antibody | ||||||
| Heavy Chain Sequence |
QVQLQESGPGLVKPSETLSLTCTVSGGSISSNYAWNWIRQPPGKGLEWIGYIYYSGNTNY
NPSLKSRVTISRDTSKNQFSLKLSSVTAADTAVYYCATSYYGNSFIYWGQGTLVTVSS Click to Show/Hide
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| Light Chain Sequence |
DIVMTQSPDSLAVSLGERATINCKSSQSLLNSGNQKNYLTWYQQKPGQPPKLLIYWASTR
ESGVPDRFSGSGSGTDFTLTISSLQAEDVAVYYCQNAYSFPWTFGQGTKVEIK 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
Sonesitatug vedotin [Phase 3]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
29%
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| Patients Enrolled |
Eligibility requires ECOG 0-1, advanced solid tumors (Part A: measurable/evaluable; Part B: confirmed Claudin 18.2+ lesions). Key exclusions: recent anticancer therapies (<28 days), active infections/CNS metastases, neuropathy ≥Grade 2, uncontrolled effusions, HBV/HCV viremia, or QTc >480msec. Contraception is mandated for reproductive-age participants.
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| Administration Dosage |
CMG901 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until confirmed Progressive Disease (PD), unacceptable toxicity, initiation of new anti-tumor therapy, withdrawal from the study, or death, whichever occurs first.
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| Related Clinical Trial | |||||
| NCT Number | NCT04805307 | Clinical Status | PHASE1 | ||
| Clinical Description |
An Open-Label, Phase 1, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of CMG901 in Subjects With Advanced Unresectable or Metastatic Solid Tumor
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| Primary Endpoint |
Part A evaluates safety endpoints including AE incidence, lab abnormalities (30 days post-treatment), and MTD determination (21-day DLT window). Part B focuses on preliminary efficacy (ORR per RECIST v1.1) and RP2D establishment for Claudin 18.2+ advanced solid tumors over 24 months.
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| Other Endpoint |
Comprehensive PK analysis covers AUC (0-last/tau/inf), Cmax, Tmax, clearance, and volume parameters through 24 months, alongside immunogenicity (anti-CMG901 antibodies). Secondary endpoints include DCR, DoR, PFS, OS, and Claudin 18.2 expression correlation, with Part B adding NCI CTCAE v5.0 safety monitoring.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants (≥18yo, ECOG 0-1) required CLDN18.2+ lesions (RECIST v1.1), adequate organ function (>35kg). Substudies targeted specific cancers: GC/GEJC (≤2 prior lines), PDAC (treatment-naïve metastatic), biliary tract (1-2 prior lines). Key exclusions: active GI bleeding, ascites, ILD history, CNS metastases, prior MMAE-ADC/CLDN18.2 therapy (except antibodies), QTc risks (Substudy 1), UGT1A1/CYP3A4 interactions (Substudy 2), or biliary obstruction (Substudy 3).
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| Administration Dosage |
Substudy 1 is recruiting patients with human epidermal growth factor receptor 2 (HER2)-negative, CLDN18.2-expressing G/GEJ cancer with ≤2 prior lines of therapy for unresectable or metastatic disease, who are randomized 1:1 to receive AZD0901 1.8 or 2.2 mg/kg intravenous (IV) every 3 weeks (Q3W).
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| Related Clinical Trial | |||||
| NCT Number | NCT06219941 | Clinical Status | PHASE2 | ||
| Clinical Description |
A Phase II, Open-label, Multi-centre Study to Evaluate Safety, Tolerability, Efficacy, PK, and Immunogenicity of AZD0901 as Monotherapy and in Combination With Anti-cancer Agents in Participants With Advanced Solid Tumours Expressing Claudin 18.2 (CLARITY-PanTumour01)
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| Primary Endpoint |
Safety monitoring included AEs/SAEs, lab/vital sign changes, DLTs (30 days post-treatment; AE follow-up for 90 days). Primary objective assessed AZD0901's safety (monotherapy/combination) in CLDN18.2+ advanced/metastatic solid tumors, analyzing discontinuation rates and tolerability.
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| Other Endpoint |
Efficacy measures included ORR (RECIST v1.1), OS, PFS (both ~2 years), DoR, DCR (11-week landmark), and tumor shrinkage percentage. PK analysis covered serum concentrations (AZD0901/MMAE) and parameters (AUC/Cmax/tmax) until 90 days post-treatment, alongside immunogenicity (ADA) and biomarker correlations (tissue-based RNA/DNA/proteins) during early treatment.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
75%
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| Patients Enrolled |
Patients with advanced malignant tumors.
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| Administration Dosage |
Day 1 in 3-week (Q3W) cycle 3.40 mg/kg.
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| Related Clinical Trial | |||||
| NCT Number | NCT04805307 | Clinical Status | Phase 1 | ||
| Clinical Description |
An open-label, phase 1, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of CMG901 in subjects with advanced unresectable or metastatic solid tumor.
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References