Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0WFJHW)
| ADC Name |
BAT8009
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| Synonyms |
BAT8009
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| Organization |
Bio-Thera Solutions (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Antibody Name |
Anti-B7H3 antibody
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Antibody Info | ||||
| Antigen Name |
CD276 antigen (CD276)
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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 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 participants must be 18-75 years old with advanced/metastatic solid tumors refractory to standard therapy, adequate organ function, and measurable disease per RECIST v1.1, while exclusions involve pregnancy, active CNS metastases, recent major surgery, severe infections, HIV/hepatitis B/C, or prior Grade 3-4 antibody therapy reactions, ensuring patient safety and protocol adherence.
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| Administration Dosage |
BAT8009 will be administered as a 90-minute (± 5min) IV infusion on Day 1 of Cycle 1. If there is no infusion related reaction after initial dose, the next dose of BAT8009 will be infused intravenously into each patient for approximately 30~120 minutes.
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| Related Clinical Trial | |||||
| NCT Number | NCT05405621 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1, Multi-Center, Open-Label Study to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BAT8009 in Patients With Advanced Solid Tumours | ||||
| Primary Endpoint |
The primary endpoint assesses dose-limiting toxicity (DLT) occurring within 21 days post-initial BAT8009 administration, defining toxicity parameters during the observation period to evaluate safety tolerability.
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| Other Endpoint |
Secondary endpoints include pharmacokinetic measures like Cmax (maximum serum concentration) and AUC0-inf/AUC0-λ over 126 days, alongside immunogenicity monitoring for anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to characterize drug exposure and immune response profiles.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05405621 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1, multi-center, open-label study to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of BAT8009 in patients with advanced solid tumours. | ||||
References