Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0TWLXC
ADC Name
SBT6290
Synonyms
SBT6290
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Organization
Silverback Therapeutics (ARS Pharmaceuticals) (Originator)
Drug Status
Phase 1/2 (discontinued)
Antibody Name
Anti-Nectin-4 antibody
  Antibody Info 
Antigen Name
Nectin-4 (NECTIN4)
  Antigen Info 
Payload Name
TLR8 agonist
  Payload Info 
Therapeutic Target
Toll-like receptor 8 (TLR8)
  Target Info 
Linker Name
Undisclosed
Conjugate Type
Random Cysteines
The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
Indication Phase 1 Phase 1/2 Phase 2 Phase 2/3 Phase 3 New Drug Application Approved
Breast cancer
1 Trials
Trial ID
NCT05234606
Head and neck cancer
1 Trials
Trial ID
NCT05234606
Lung cancer
1 Trials
Trial ID
NCT05234606
Urothelial cancer
1 Trials
Trial ID
NCT05234606
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05234606
PHASE1|||PHASE2
A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD- (L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Eligible patients have Nectin-4-expressing advanced/metastatic solid tumors (e.g., urothelial carcinoma, TNBC, NSCLC), measurable disease (RECIST 1.1), ECOG 0-1, and adequate organ function. Exclusions include untreated brain metastases, active autoimmune disease, high-dose steroids (>10mg prednisone/day), uncontrolled ILD, significant ocular disorders, or active HIV/HBV/HCV infections. Archived/accessible tumor tissue for Nectin-4 testing is required.

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Administration Dosage
Escalating doses by subcutaneous (SC) injection in 21-day cycles
Related Clinical Trial
NCT Number NCT05234606  Clinical Status PHASE1|||PHASE2
Clinical Description A Phase 1/2, Open-Label, Dose-Escalation and Expansion Study of SBT6290 Alone and in Combination With PD- (L)1 Inhibitors in Subjects With Advanced Solid Tumors Associated With Nectin-4 Expression
Primary Endpoint
The primary safety endpoints include dose-limiting toxicities (DLTs) within 28 days post-first SBT6290 dose (Part 1/3) and treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0 across all study parts, monitored until 30 days post-treatment (up to 2 years). Efficacy measures for Part 2/4 include objective response rate (ORR; RECIST 1.1) and duration of response (DOR), tracked until progression/death (up to 3 years).

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Other Endpoint
Secondary outcomes assess ORR/DOR in Part 1/3, disease control rate (DCR; CR/PR/SD) for ≥6 months, and progression-free survival (PFS; Part 2). Pharmacokinetics (Cmax, AUC) and antidrug antibody (ADA) incidence are evaluated pre-/post-dose for 2 years.
References
Ref 1 A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors