Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0WFJHW
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| 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 indication landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | 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 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