Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0FKOLH
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| ADC Name |
DB-1310
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| Synonyms |
DB-1310
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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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| Structure |
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| Antibody Name |
Anti-HER3 IgG1 mAb
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-3 (ERBB3); Tumor-associated calcium signal transducer 2 (TACSTD2)
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Antigen Info | ||||
| Payload Name |
P1021
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
drozuntecan
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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 | ||
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| Unspecific solid tumor |
1 Trials
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ADC-specific functional property(2027 Update)
Bystander Killing Effect
| Bystander Killing Effect | Description | Reference |
|---|---|---|
| yes |
The bystander killing effect of DB-1310 was determined by comparison of cell killing in a monoculture of HER3-negative HEK293 cells and a coculture of HEK293 cells with HEK293-ERBB3 cells, a HER3-expressing 293T cell line. When used at 0.5 nM, DB-1310 inhibited the proliferation of HEK293 cells in the coculture system but not in the monoculture system, indicating that DB-1310 exerts a bystander killing effect
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General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Time to Maximum Concentration (Tmax) | 0.083 | h |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Serum.
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| Maximum Observed Concentration (Cmax) | 90996 | ng/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Serum.
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| Area Under the Concentration-Time Curve (AUC) | 4355036 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Serum, AUC0-t.
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| Time to Maximum Concentration (Tmax) | 48 | h |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Tumor.
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| Maximum Observed Concentration (Cmax) | 5021 | ng/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Tumor.
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| Area Under the Concentration-Time Curve (AUC) | 558242 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Tumor, AUC0-t.
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Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 4355036 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Serum, AUC0-t.
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| Area Under the Concentration-Time Curve (AUC) | 558242 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Tumor, AUC0-t.
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Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 4355036 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Serum, AUC0-t.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 558242 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Tumor, AUC0-t.
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Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Elimination Half-Life (t1/2) | 119 | h |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Serum.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 4355036 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Serum, AUC0-t.
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[1] |
| Elimination Half-Life (t1/2) | 88.4 | h |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Tumor.
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[1] |
| Area Under the Concentration-Time Curve (AUC) | 558242 | ng*h/mL |
PK parameters of DB-1310 (5 mg/kg, i.v.) in the NCI-H441 model, Tumor, AUC0-t.
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[1] |
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 | [2] | ||||
| Patients Enrolled |
Eligible participants are adults (≥18) with progressing solid tumors after standard therapy, measurable disease per RECIST 1.1, ECOG 0-1, and adequate organ/cardiac function. Key exclusions include prior HER3/topoisomerase I inhibitor ADC therapy (with exceptions), significant cardiac/corneal/pulmonary conditions, active untreated CNS metastases, uncontrolled infections, QTc >470ms, and active hepatitis/HIV. Reproductive requirements mandate contraception for 4-7 months post-treatment.
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| Administration Dosage |
DB-1310 is administrated intravenously every 3 weeks as monotherapy, or plus trastuzumab in pts with HER2-positive BC only, until discontinuation criteria are met. The study plans to enroll approximately 95 pts in Phase 1 and 192 in Phase 2a from the United States and China.
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| Related Clinical Trial | |||||
| NCT Number | NCT05785741 | 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-1310 in Subjects With Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
Phase 1 evaluates safety parameters including dose-limiting toxicities (DLTs) during Cycle 1 and treatment-emergent adverse events (TEAEs)/serious adverse events (SAEs) over approximately 1 year, while determining Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of DB-1310. Phase 2a continues monitoring TEAEs/SAEs while assessing efficacy through Objective Response Rate (ORR) per RECIST 1.1 over 1 year.
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| Other Endpoint |
Pharmacokinetic assessments (AUC, Cmax, Tmax, T1/2) for DB-1310 components are conducted across both phases within 8 treatment cycles (21 days each). Efficacy evaluations include ORR, duration of response (DOR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) per RECIST 1.1, with investigator-assessed tumor responses.
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References