Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ID: DRG0SNDEK)
| ADC Name |
DB-1419
|
|||||
|---|---|---|---|---|---|---|
| Synonyms |
DB-1419
Click to Show/Hide
|
|||||
| Organization |
Duality Biotherapeutics (DualityBio) (Originator)
|
|||||
| Drug Status |
Phase 1/2
|
|||||
| Drug-to-Antibody Ratio |
8
|
|||||
| Antibody Name |
Anti-B7H3/PDL1 bsAb
|
Antibody Info | ||||
| Antigen Name |
CD276 antigen (CD276); Programmed cell death 1 ligand 1 (PD-L1)
|
Antigen Info | ||||
| Payload Name |
P1003
|
Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
|
Target Info | ||||
| Linker Name |
A tetra-peptide based cleavable linker
|
Linker Info | ||||
| Conjugate Type |
Random Cysteines
|
|||||
2027 Update
The disease landscape of This ADC
2027 Update
The clinical trial pipelines of This ADC
| Indication | Phase 1 | Phase 2 | Phase 3 | Approved | ||
|---|---|---|---|---|---|---|
| Unspecific solid tumor |
1 Trials
|
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.
|
||||
| Administration Dosage |
.
|
||||
| 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).
|
||||
| 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.
|
||||