Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0SNDEK)
| ADC Name |
DB-1419
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| Synonyms |
DB-1419
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| Organization |
Duality Biotherapeutics (DualityBio) (Originator)
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| Drug Status |
Phase 1/2
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| Drug-to-Antibody Ratio |
8
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| Antibody Name |
Anti-B7H3/PDL1 bsAb
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Antibody Info | ||||
| Antigen Name |
CD276 antigen (CD276); Programmed cell death 1 ligand 1 (PD-L1)
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Antigen Info | ||||
| Payload Name |
P1003
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Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
A tetra-peptide based cleavable linker
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
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 |
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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| Administration Dosage |
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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 | ||||
| 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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