Linker Information
General Information of This Linker
| Linker ID |
LIN0FINGX
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| Name |
Hydrolysable linker
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| Linker Type |
Unclear
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| Antibody-Linker Relation |
Cleavable
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
AMT-116 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients are aged 18-70 with melanoma, NSCLC (squamous), or head and neck SCC, confirmed target protein expression, and adequate organ function. Exclusions include active HBV/HCV/HIV, prior CAR-T therapy, immunosuppressant use, severe comorbidities, or pregnancy. Subjects must consent and comply with follow-up.
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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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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients are aged 18-70 with melanoma, NSCLC (squamous), or head and neck SCC, confirmed target protein expression, and adequate organ function. Exclusions include active HBV/HCV/HIV, prior CAR-T therapy, immunosuppressant use, severe comorbidities, or pregnancy. Subjects must consent and comply with follow-up.
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| Administration Dosage |
Pts received escalating doses of AMT-116 Q2W starting from 1.5 mg/kg guided by the Bayesian logistic regression model (BLRM) following escalation with overdose control (EWOC) principle.
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| Related Clinical Trial | |||||
| NCT Number | NCT05725291 | Clinical Status | PHASE1 | ||
| Clinical Description |
First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors
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| Primary Endpoint |
Safety and efficacy endpoints include incidence of adverse events, Overall Response Rate (ORR), and 1-year recurrence rate, all assessed over a 24-week timeframe.
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| Other Endpoint |
Key survival metrics include Progression-Free Survival (PFS) and Relapse-Free Survival (RFS), both evaluated over a 24-week period.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients ≥18 years with progressive advanced solid tumors after prior therapy, adequate organ function and measurable disease. Key exclusions: prior Top1-ADC therapy, CNS metastases, major cardiac disease, recent systemic therapy/surgeries, ocular disorders, or active skin conditions requiring treatment. Both genders must comply with contraception requirements.
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| Related Clinical Trial | |||||
| NCT Number | NCT06782334 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
Phase 1/2 Study of AMT-116 in Patients with Advanced Solid Tumors
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| Primary Endpoint |
Primary safety and dosing parameters include determination of RP2D and MTD based on DLTs over 24 months, along with comprehensive assessment of adverse events using CTCAE v5.0 criteria.
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| Other Endpoint |
Efficacy measures include ORR, DCR and PFS per RECIST v1.1, along with extensive pharmacokinetic characterization of AMT-116 (ADA, Cmax, AUC, t1/2, Tmax) over 24 months of evaluation.
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References