Antibody Information
General Information of This Antibody
| Antibody ID | ANTI0WEFUI |
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| Antibody Name | A humanized anti-MUC18 IgG1 mAb |
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| Antigen Name | Muc18 |
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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
AMT-253 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients aged 18-70 with histopathologically confirmed melanoma, non-small cell lung cancer (squamous), or head/neck squamous cell carcinoma must meet specific criteria including target protein expression, adequate venous access, and proper blood/liver/kidney function; exclusion factors cover active infections, prior CAR-T therapy, immunosuppressant use, severe systemic/autoimmune diseases, pregnancy, allergies, or prior organ transplants.
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| Related Clinical Trial | |||||
| NCT Number | NCT05117138 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
Safety and Efficacy of Chimeric Antigen Receptor T Lymphocytes for Patients With Intermediate and Advanced Tumors
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| Primary Endpoint |
Primary endpoints include incidence of adverse events, overall response rate (ORR), and one-year recurrence rate, all evaluated over a 24-week timeframe.
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| Other Endpoint |
Secondary endpoints comprise progression-free survival (PFS) and relapse-free survival (RFS), also measured within a 24-week period.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligibility requires signed ICF, advanced solid tumors, progression after prior therapy, measurable lesions, ECOG 0-1, ≥3 month life expectancy, adequate organ function, and contraceptive use. Exclusions include prior target therapy, CNS metastases, severe skin disorders, unresolved toxicities (>Grade 1), recent treatments/surgeries, cardiac issues, thromboembolic events, active infections, or recent live vaccines.
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| Administration Dosage |
Administered intravenously
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| Related Clinical Trial | |||||
| NCT Number | NCT06209580 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
Phase I/II Study of AMT-253 in Patients With Unresectable or Metastatic Malignant Melanoma and Other Advanced Solid Tumors
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| Primary Endpoint |
The study assesses DLTs (21 days post-dose), AEs/SAEs (24 months) including type, incidence and severity, and ORR per RECIST 1.1.
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| Other Endpoint |
Pharmacokinetic metrics over 24 months include Cmax, Tmax, AUC, t1/2 of ADC components, and ADA quantification.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients must be ≥18 years, with progressive disease after systemic therapy, measurable lesions per RECIST v1.1, ECOG 0-1, adequate organ function, and life expectancy ≥3 months. Key exclusions include CNS metastasis, active infections, significant cardiac/autoimmune diseases, recent major surgery/radiotherapy, unresolved toxicities >Grade 1, pregnancy, or prior malignancies within 5 years (unless inclusion-related). Contraception and tumor tissue availability are required.
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| Administration Dosage |
Administered intravenously
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| Related Clinical Trial | |||||
| NCT Number | NCT05906862 | Clinical Status | PHASE1 | ||
| Clinical Description |
First-in-Human, Phase 1 Study of AMT-253, in Patients With Advanced Solid Tumors
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| Primary Endpoint |
The study focuses on determining the Recommended Phase 2 Dose (RP2D) and Maximum Tolerated Dose (MTD) based on dose-limiting toxicities (DLTs) and other data over 24 months. Safety and tolerability will be assessed using Common Terminology Criteria for Adverse Events v5.0 to evaluate adverse event types, incidence, and severity.
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| Other Endpoint |
Key efficacy endpoints include Overall Response Rate (ORR) and Disease Control Rate (DCR) per RECIST v1.1, along with Progression-free Survival (PFS). Pharmacokinetic profiling will assess Cmax, AUC, terminal half-life (t1/2), and Tmax of AMT-253, while immunogenicity will be evaluated via anti-drug antibody (ADA) concentrations, all measured over 24 months.
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References