Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0RCHSE
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| ADC Name |
SKB315
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| Synonyms |
SKB315; A315; MK-1200
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| Organization |
Kelun Biotherapeutics (Originator);Merck & Co. (Top20 MNC) (No Rights)
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| Drug Status |
Phase 1/2
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| Drug-to-Antibody Ratio |
7~8
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| Antibody Name |
Anti-CLDN18.2 antibody
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Antibody Info | ||||
| Antigen Name |
Claudin-18.2 (CLDN18.2)
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Antigen Info | ||||
| Payload Name |
Belotecan-derivative
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Kthiol (pyrimidine-thiol) oligopeptide 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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| Oesophageal cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Gastric cancer |
1 Trials
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1 Trials
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| Pancreatic cancer |
1 Trials
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| Biliary tract cancer |
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 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 | ||||
| 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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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| 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. | ||||
References