Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0MWSEV
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| ADC Name |
NN3201
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| Synonyms |
NN3201
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| Organization |
Novelty Nobility (Originator)
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| Drug Status |
Phase 1
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
NN2101
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Antibody Info | ||||
| Antigen Name |
Mast/stem cell growth factor receptor Kit (KIT)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Bis-sulfone-(PEG24)-Glu-Val-Cit-PAB
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Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||
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| Gastrointestinal stromal cancer |
1 Trials
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| Kidney cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Melanoma |
1 Trials
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| Unspecific solid tumor |
1 Trials
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ADC-specific functional property(2027 Update)
Bystander Killing Effect
| Bystander Killing Effect | Description | Reference |
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| yes |
Moreover, bystander effect was confirmed by co-culturing c-Kit high and negative cell lines.
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[1]
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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 | [2] | ||||
| Patients Enrolled |
Eligible subjects (≥18 years, ECOG 0-1) must have advanced c-Kit+ tumors (GIST, SCLC, ACC, uveal melanoma, NET ChRCC/ccRCC) refractory to standard therapies, including imatinib for GIST. Required washout periods: 21 days (chemotherapy), 14 days (targeted therapy), 28 days (immunotherapy). Exclusions include active brain metastases, uncontrolled infections, significant cardiovascular disease, recent major surgery, COVID-19 infection, or pregnancy. Adequate organ function and contraception (120 days post-treatment) are mandatory.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06805825 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Dose Escalation and Expansion Study of the C-Kit Specific Antibody-Drug Conjugate NN3201 in Subjects with Advanced And/or Metastatic Solid Tumors Known to Express C-Kit | ||||
| Primary Endpoint |
The study evaluates safety by assessing dose-limiting toxicities (DLTs) within 3 weeks post-treatment, defined as clinically relevant AEs per NCI CTCAE v5.0 that are attributed to NN3201. Adverse event incidence (severity, seriousness, and drug relationship) is monitored over 1 year.
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| Other Endpoint |
The trial determines optimal doses for expansion cohorts (within 1 year) by analyzing anti-tumor efficacy and acceptable safety profiles. Pharmacokinetic (PK) analysis measures NN3201 serum concentration over 3 years, while RECIST 1.1 assesses anti-tumor activity. Promising doses may advance to future studies based on sustained efficacy and safety (3-year timeframe).
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References