Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0NHPIU
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| 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 indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
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| Unspecific solid tumor |
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 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