Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0AVQWJ)
| ADC Name |
BAT8003
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| Synonyms |
BAT8003
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| Organization |
Bio-Thera Solutions (Originator);Insud Pharma
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
3.5
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| Structure |
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| Antibody Name |
Anti-TROP2 antibody
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
Batansine
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Payload Info | ||||
| Payload Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Maleimido-caproyl
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Linker Info | ||||
| Conjugate Type |
Reactive Cysteines
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| Combination Type |
batansine
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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 18-75 with advanced Trop2-positive epithelial cancer, measurable lesions (RECIST 1.1), ECOG 0-1, adequate organ function, and recovery from prior therapy (≤Grade 1 AEs, except alopecia). Exclusion criteria include active HBV/HCV/syphilis, immunodeficiency, uncontrolled infections, severe cardiopulmonary disease, CNS metastases, Grade ≥2 neuropathy, recent clinical trial participation, major surgery, strong CYP3A4 inhibitor use, allergies, pregnancy, substance abuse, or other investigator-deemed ineligibility.
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| Administration Dosage |
Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result
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| Related Clinical Trial | |||||
| NCT Number | NCT03884517 | Clinical Status | PHASE1 | ||
| Clinical Description | An Open, Escalating Phase I Clinical Trial of BAT8003 (for Injection) on the Safety, Tolerability and Pharmacokinetics for Patients With Advanced Epithelial Cancer | ||||
| Primary Endpoint |
The study assesses dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) as safety/tolerability endpoints over 3 weeks. Pharmacokinetic parameters include AUC, Cmax, t1/2, and Tmax, measured within 24 weeks.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT03884517 | Clinical Status | Phase 1 | ||
| Clinical Description | An open, escalating phase 1 clinical trial of BAT8003 (for injection) on the safety, tolerability and pharmacokinetics for patients with advanced epithelial cancer. | ||||
References