Antibody Information
General Information of This Antibody (ID: ANTI0RKEMD)
| Antibody Name | MIW338 |
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| Antigen Name | HER2 |
Antigen Info | ||||
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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
NJH395 [Phase 1 (discontinued)]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible patients must have HER2+ non-breast solid tumors refractory to standard therapies (ECOG ≤2) with biopsy-accessible lesions. Key exclusions include prior TLR7/8 treatment, cardiac dysfunction, autoimmune/active lung diseases, HIV, checkpoint inhibitor toxicity history, or QT-prolonging drug use. Additional protocol criteria may apply.
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| Administration Dosage |
As of July 01, 2020, 18 patients (10 males, 8 females; median age, 52.5 years [range, 42-74 years]) were enrolled in 5 dose cohorts (0.1-1.6 mg/kg).
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| Related Clinical Trial | |||||
| NCT Number | NCT03696771 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase I, Multicenter, Open-label Dose Finding Study of NJH395, Administered Intravenously in Patients With Non-breast HER2+ Advanced Malignancies
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| Primary Endpoint |
Dose-limiting toxicities (DLTs) incidence and severity will be assessed over 21 days, extending to 42 days in the second study phase. Adverse event data collection spans 2.5 years.
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| Other Endpoint |
PK profiles for NJH395 and metabolites will be tracked for 126 days, including Cmax/AUC measurements. Anti-drug antibody assessment and efficacy endpoints (ORR, CBR, PFS, DOR per RECIST v1.1/iRECIST) will be evaluated over 2.5 years. Tumor infiltrating lymphocyte changes will be monitored via IHC at specified treatment cycles (21-day intervals).
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
0%
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| Patients Enrolled |
Patients with nonbreast HER2+ advanced malignancies.
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| Administration Dosage |
5 dose cohorts (0.10-1.60 mg/kg).
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| Related Clinical Trial | |||||
| NCT Number | NCT03696771 | Clinical Status | Phase 1 | ||
| Clinical Description |
A phase 1, multicenter, open-label dose finding study of NJH395, administered intravenously in patients with non-breast HER2+ advanced malignancies.
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References