Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0AVQWJ
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| 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); Programmed cell death 1 ligand 1 (PD-L1)
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Antigen Info | ||||
| Payload Name |
Batansine
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Payload Info | ||||
| Therapeutic 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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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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| Urothelial cancer |
1 Trials
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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 18-75 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