Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0AJCCS
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| ADC Name |
BAT8008
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| Synonyms |
BAT8008
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| Organization |
Bio-Thera Solutions (Originator)
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| Drug Status |
Phase 2
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| Drug-to-Antibody Ratio |
6
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| Antibody Name |
Anti-TROP2 antibody
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Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
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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 |
Maleimide tetrapeptide-based cleavable linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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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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2027 Update
ADC-specific functional property
Circulating Stability
| Incubation Time | 7days | Release | <1% | Reference |
[1]
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| Incubation Medium | monkey serum | ||||
| Description |
Less than 0.1% of the payload was released from BAT8008 when incubated with human or monkey plasma for 7 days in 37°C, suggesting the stability of BAT8008 in blood circulation.
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| Incubation Time | 7days | Release | <1% | Reference |
[1]
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| Incubation Medium | human serum | ||||
| Description |
Less than 0.1% of the payload was released from BAT8008 when incubated with human or monkey plasma for 7 days in 37°C, suggesting the stability of BAT8008 in blood circulation.
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Bystander Killing Effect
| Bystander Killing Effect | Description | Reference |
|---|---|---|
| yes |
In an in vitro bystander killing assay, proliferation of Trop-2-negative cells was potently inhibited by addition/transfer of culture medium of BAT8008-treated Trop-2-positive cells, but not that of BAT8008-treated Trop-2-negative cells, indicating the bystander killing effect of the released payload in the culture medium.
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[1]
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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 | [2] | ||||
| Patients Enrolled |
Eligible patients are adults (≥18 years) with histologically confirmed advanced/metastatic solid tumors refractory to standard therapy, measurable lesions per RECIST 1.1, ECOG PS 0-1, adequate organ function, and compliance with contraception. Exclusions involve recent experimental/tumor therapy (within 4 weeks), prior Trop2-targeted treatment, severe topoisomerase I inhibitor toxicity, major surgery (within 4 weeks), or organ transplantation history.
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| Administration Dosage |
.
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| Related Clinical Trial | |||||
| NCT Number | NCT05620017 | Clinical Status | PHASE1 | ||
| Clinical Description | A Multicenter, Open Phase I Clinical Study to Evaluate the Safety, Tolerance, Pharmacokinetics and Initial Efficacy of BAT8008 for Injection in Patients With Advanced Solid Tumor | ||||
| Primary Endpoint |
The primary endpoints include dose-limiting toxicity (DLT), defined as grade ≥3 toxicity related to the investigational product within the first 21-day cycle, and maximum tolerated dose (MTD), determined as the highest dose with ≤1/6 subjects experiencing DLT during evaluation.
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| Other Endpoint |
Pharmacokinetic analysis includes AUC (0-inf) after cycle 6, measuring the area under the concentration-time curve from time 0 extrapolated to infinity, assessed 91 days post-first dose.
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible patients are adults (≥18) with advanced/metastatic epithelial solid tumors (e.g., triple-negative breast cancer, NSCLC) refractory to standard therapy, measurable lesions (RECIST 1.1), ECOG PS 0-1, and adequate organ function. Key exclusions: recent experimental/anti-tumor therapy (4 weeks), prior Trop2-ADC/toisomerase I inhibitor toxicity, uncontrolled CNS metastases, active infections (HIV/HBV/HCV), severe cardiovascular disease, or immunosuppressive therapy within 14 days.
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| Administration Dosage |
BAT1308 injection: 25 mg/mL concentrate for solution for infusion.200 mg on Day 1 of each 14-day cycle BAT8008 injection: 20 mg/mL concentrate for solution for infusion.Climbing group A: 2.1mg/kg on Day 1 of each 14-day cycle,and Climbing group B: 2.4mg/kg on Day 1 of each 14-day cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT06341114 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Multicenter, Open-label Phase Ib-II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of the Combination of BAT8008 With BAT1308 in Patients With Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary outcomes include dose-limiting toxicity (DLT) assessed within the first 21-day cycle, vital signs, physical exams, adverse events (AEs) per CTCAE v5.0, clinical lab abnormalities, and efficacy metrics (ORR, DOR, DCR, PFS, and OS) evaluated over a 1-year period via RECIST 1.1 criteria.
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| Other Endpoint |
Pharmacokinetic parameters (Tmax, CL, t½, Cmax, ADA, and Nab levels) are assessed at multiple timepoints across cycles (C1D1-C4D1, then every 4 cycles up to 26 cycles, each lasting 2 weeks).
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References