Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0KHDFE)
| ADC Name |
BAT8007
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| Synonyms |
BAT8007
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| Organization |
Bio-Thera Solutions (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
8
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| Antibody Name |
Anti-Nectin-4 antibody
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Antibody Info | ||||
| Antigen Name |
Nectin-4 (NECTIN4)
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Antigen Info | ||||
| Payload Name |
Exatecan
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
A cleavable but systemically stable linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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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 (18-75 years, ECOG 0-1) must have advanced solid tumors failing standard therapy, measurable lesions per RECIST 1.1, and adequate organ function. Key exclusions include prior Nectin-4 treatment, uncontrolled cardiovascular disease (NYHA≥2, QTc>450/470ms), active HIV/HBV/HCV/syphilis, untreated tuberculosis, recent major surgery/thromboembolism, or live vaccinations within 4 weeks. COVID-19 vaccination requires ≥14-day separation from treatment initiation.
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| Administration Dosage |
Subjects with advance solid tumor received BAT8007 on day 1 of a 21-day cycle until subject intolerance or disease progression.
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| Related Clinical Trial | |||||
| NCT Number | NCT05879627 | Clinical Status | PHASE1 | ||
| Clinical Description | A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetics of BAT8007 for Injection in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
The study will assess dose-limiting toxicities (DLTs) within 21 days post-initial BAT8007 dose using NCI CTCAE v5.0, alongside continuous adverse event (AE) monitoring from first dose to 28 days post-treatment or until new antitumor therapy begins.
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| Other Endpoint |
Immunogenicity (ADA levels) and neutralizing antibodies (NAb) will be tracked through Cycle 3 (14-day cycles), alongside pharmacokinetic analyses including Cmax, Tmax, T1/2, and systemic clearance.
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References