Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0NHPIU)
| ADC Name |
AMT-116
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| Synonyms |
AMT-116; AMT-116 ADC; AMT116
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| Organization |
Multitude Therapeutics (Originator)
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| Drug Status |
Phase 1/2
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| Drug-to-Antibody Ratio |
7~8
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| Antibody Name |
Anti-CD44v9 antibody
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Antibody Info | ||||
| Antigen Name |
CD44v9
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Antigen Info | ||||
| Payload Name |
KL610023
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Hydrolysable linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
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 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 |
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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 | ||||
| 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 | ||||
| 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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| Administration Dosage |
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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 | ||||
| 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