Linker Information
General Information of This Linker (ID: LIN0VZGOJ)
| Name |
A tetra-peptide based 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
DB-1419 [Phase 1/2]
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Key inclusion criteria: age ≥18; ECOG 0-1; advanced/metastatic solid tumors refractory to standard therapy; ≥1 measurable lesion (RECIST v1.1); life expectancy ≥3 months; LVEF ≥50%; adequate organ function; tumor sample availability for biomarker analysis; written informed consent.
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| Related Clinical Trial | |||||
| NCT Number | NCT06554795 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description |
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1419 in Participants with Advanced/Metastatic Solid Tumors
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| Primary Endpoint |
Primary endpoints include AE/SAE rates (NCI CTCAE v5.0) within 30 days post-treatment, MTD/RP2D determination in Phase 1a (12 months), and investigator-assessed ORR (CR+PR per RECIST v1.1) in Phase 1b/2a (12 months).
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| Other Endpoint |
Secondary endpoints comprise ORR, PFS, OS (12 months), PK parameters (AUC0-last, AUC0-tau, AUCinf, Cmax, Tmax, Ctrough within 8 cycles), and ADA prevalence/incidence (8 cycles) in Phase 1/2a populations.
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