Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0KHDFE
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| 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 | ||||
| Therapeutic 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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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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| 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 (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