Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0ZLJPV)
| ADC Name |
SKB410
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| Synonyms |
SKB410; MK-3120
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| Organization |
Kelun Biotherapeutics (Originator);Merck & Co. (Top20 MNC)
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| Drug Status |
Phase 1/2
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| Antibody Name |
Anti-Nectin-4 antibody
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Antibody Info | ||||
| Antigen Name |
Nectin-4 (NECTIN4)
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Antigen Info | ||||
| Payload Name |
TOP1 inhibitor
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Undisclosed
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| Conjugate Type |
Undisclosed
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Disease Name | Phase 1 | Phase 2 | Phase 3 | Approved |
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| Urothelial cancer | ||||
| Unspecific solid tumor |
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 must have advanced solid tumors (RECIST 1.1 measurable), ECOG 0-1, and adequate organ function. Key exclusions include active inflammatory bowel disease, uncontrolled cardiovascular/CNS conditions, recent anticancer therapies (within 2-4 weeks), active HBV/HCV/HIV co-infections (unless controlled), or symptomatic effusions requiring drainage.
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| Administration Dosage |
Participants receive MK-3120 at dose level 1/2 as per the schedule specified in the arm.
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| Related Clinical Trial | |||||
| NCT Number | NCT06818643 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-3120 in Participants With Advanced Solid Tumors | ||||
| Primary Endpoint |
The primary safety outcomes include incidence of adverse events (AEs) and treatment discontinuations due to AEs over ~30 months, capturing all medically significant occurrences regardless of causality.
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| Other Endpoint |
Efficacy measures assess objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS) per RECIST 1.1 over ~34 months, alongside pharmacokinetic parameters (AUC, Cmin, Cmax) of MK-3120 monitored for ~4 months.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants must be ≥18 years with advanced solid tumors (RECIST v1.1 measurable), ECOG 0-1, and adequate organ function. Key exclusions include recent anti-tumor therapies (within 4 weeks/5 half-lives), active CNS metastases, uncontrolled cardiovascular/autoimmune diseases, HIV/active hepatitis infections, pregnancy/lactation, or prior stem cell/organ transplantation.
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| Administration Dosage |
SKB410 for injection is administered every 2 weeks (q2w) until radiographic disease progression (PD), intolerable toxicity, death, or discontinuation of treatment, whichever occurs first.
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| Related Clinical Trial | |||||
| NCT Number | NCT05906537 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SKB410 for Injection in Subjects with Advanced Solid Tumors | ||||
| Primary Endpoint |
Phase Ia evaluates dose-limiting toxicities (DLTs) and maximum tolerated dose (MTD) within 28 days post-treatment initiation, while Phase Ib assesses objective response rate (ORR) per RECIST v1.1 over approximately 2 years.
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References