Linker Information
General Information of This Linker
| Linker ID |
LIN0SFBWA
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| Name |
Maleimide tetrapeptide-based cleavable linker
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| Linker Type |
Cathepsin-cleavable linker
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| Antibody-Linker Relation |
Cleavable
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Each Antibody-drug Conjugate Related to This Linker
Full Information of The Activity Data of The ADC(s) Related to This Linker
BAT8008 [Phase 2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| 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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| 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
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| 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 | [2] | ||||
| 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
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| 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