Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0DLKUH
|
|||||
|---|---|---|---|---|---|---|
| ADC Name |
Sacituzumab drozuntecan
|
|||||
| Synonyms |
DB-1305; BNT325
Click to Show/Hide
|
|||||
| Organization |
Duality Biotherapeutics (DualityBio) (Originator);BioNTech
|
|||||
| Drug Status |
Phase 1/2
|
|||||
| Drug-to-Antibody Ratio |
~4
|
|||||
| Structure |
|
|||||
| Antibody Name |
Anti-TROP2 antibody
|
Antibody Info | ||||
| Antigen Name |
Tumor-associated calcium signal transducer 2 (TACSTD2)
|
Antigen Info | ||||
| Payload Name |
P1021
|
Payload Info | ||||
| Payload Target |
DNA topoisomerase 1 (TOP1)
|
Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
|
Linker Info | ||||
| Conjugate Type |
Random Cysteines
|
|||||
| Combination Type |
drozuntecan
|
|||||
2027 Update
The indication 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
|
|||||
| Pancreatic cancer |
1 Trials
|
|||||
| Lung cancer |
1 Trials
|
|||||
| Pleura mesothelioma |
1 Trials
|
|||||
| Breast cancer |
1 Trials
|
|||||
| Ovarian cancer |
1 Trials
|
|||||
| Endometrial cancer |
1 Trials
|
|||||
| Cervical cancer |
1 Trials
|
|||||
| Prostate cancer |
1 Trials
|
|||||
| Head and neck cancer |
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] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
30.40%
|
|||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-1, measurable lesions, LVEF≥50%) must provide tumor samples for biomarker analysis; exclusions include active cardiac/ILD conditions, uncontrolled infections, AIDS-defining HIV illness, or QTcF>470ms.
|
||||
| Administration Dosage |
In Ph1, DB-1305 was planned to be administered from 2 mg/kg to 8 mg/kg (Q3W, iv) in a 3+3 design with accelerated titration for the starting dose; additional pts were enrolled to determine the recommended phase 2 dose (RP2D).
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05438329 | 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-1305 in Subjects with Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
Phase 1 evaluates DLTs within 21 days of initial dosing and monitors TEAEs/SAEs up to 30 days post-treatment, determining MTD and RP2D of DB-1305/BNT325 over ~12 months; Phase 2a assesses safety (TEAEs/SAEs) and efficacy (ORR) using RECIST 1.1 until disease progression or ~12 months.
|
||||
| Other Endpoint |
Efficacy measures (ORR, DCR, TTR, PFS, OS) and PK parameters (AUC, Cmax, Tmax, Ctrough) are evaluated over 8 cycles (21-day cycles), with immunogenicity assessed via ADA prevalence/incidence during treatment for both Phase 1 and 2a cohorts.
|
||||
| Experiment 2 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Disease control rate (DCR) |
87%
|
|||
| Patients Enrolled |
Eligible patients (≥18 years, ECOG 0-1, measurable lesions, LVEF≥50%) must provide tumor samples for biomarker analysis; exclusions include active cardiac/ILD conditions, uncontrolled infections, AIDS-defining HIV illness, or QTcF>470ms.
|
||||
| Administration Dosage |
In Ph1, DB-1305 was planned to be administered from 2 mg/kg to 8 mg/kg (Q3W, iv) in a 3+3 design with accelerated titration for the starting dose; additional pts were enrolled to determine the recommended phase 2 dose (RP2D).
|
||||
| Related Clinical Trial | |||||
| NCT Number | NCT05438329 | 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-1305 in Subjects with Advanced/Metastatic Solid Tumors | ||||
| Primary Endpoint |
Phase 1 evaluates DLTs within 21 days of initial dosing and monitors TEAEs/SAEs up to 30 days post-treatment, determining MTD and RP2D of DB-1305/BNT325 over ~12 months; Phase 2a assesses safety (TEAEs/SAEs) and efficacy (ORR) using RECIST 1.1 until disease progression or ~12 months.
|
||||
| Other Endpoint |
Efficacy measures (ORR, DCR, TTR, PFS, OS) and PK parameters (AUC, Cmax, Tmax, Ctrough) are evaluated over 8 cycles (21-day cycles), with immunogenicity assessed via ADA prevalence/incidence during treatment for both Phase 1 and 2a cohorts.
|
||||
| Experiment 3 Reporting the Activity Date of This ADC | [2] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05438329 | Clinical Status | Phase 1/2 | ||
| Clinical Description | A phase 1/2a, multicenter, open-label, non-randomized first in human study to assess the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of DB-1305 in subjects with advanced/metastatic solid tumors. | ||||
References