Linker Information
General Information of This Linker
| Linker ID |
LIN0OUECW
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| Linker Name |
Kthiol (pyrimidine-thiol) oligopeptide 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
SKB315 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05367635 | Clinical Status | Phase 1 | ||
| Clinical Description |
A phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SKB315 for injection in patients with advanced solid tumors expressing claudin 18.2.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible patients are aged 18-80 with Claudin 18.2-positive advanced solid tumors, adequate organ function, and measurable lesions. Exclusion criteria include recent anti-tumor therapies, Claudin18.2-targeted treatments, major comorbidities, or conditions affecting study compliance.
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| Administration Dosage |
SKB315 for injection is an Antibody Drug Conjugates (ADC) drug targeting Claudin18.2. The strength of SKB315 is 200 mg/vial.
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| Related Clinical Trial | |||||
| NCT Number | NCT05367635 | Clinical Status | PHASE1 | ||
| Clinical Description |
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB315 for Injection in Patients With Advanced Solid Tumors Expressing Claudin18.2
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| Primary Endpoint |
Phase 1a evaluates Dose Limiting Toxicities (DLT) within 21/28 days post-treatment initiation. Phase 1b measures Objective Response Rate (ORR) over 2 years, calculating the proportion of patients achieving Complete Response (CR) or Partial Response (PR).
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| Other Endpoint |
Key endpoints include Progression-Free Survival (PFS) and Duration of Response (DOR), both tracked for 2 years from treatment start to disease progression or death. Overall Survival (OS) is assessed from treatment initiation to any-cause death.
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References