Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0YTRFZ
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| ADC Name |
Vandortuzumab vedotin
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| Synonyms |
vandortuzumab vedotin; RG7450; DSTP3086S
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| Organization |
Roche (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
1.8~2
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| Structure |
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| Antibody Name |
Vandortuzumab
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Antibody Info | ||||
| Antigen Name |
Metalloreductase STEAP1 (STEAP1)
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Antigen Info | ||||
| Payload Name |
MMAE
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Payload Info | ||||
| Therapeutic Target |
Microtubule (MT)
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Target Info | ||||
| Linker Name |
Mc-Val-Cit-PABC
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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| Combination Type |
vedotin
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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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| Prostate cancer |
1 Trials
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General Information of The ADMET Data Related to This ADC(2027 Update)
Absorption
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) | 56 | ug/mL |
PK parameters for dstp3086s tab analytes in cycle 1 at 2.4 mg/kg.
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| Area Under the Concentration-Time Curve (AUC) | 313 | day*ug/mL |
PK parameters for dstp3086s tab analytes in cycle 1 at 2.4 mg/kg.
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Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 313 | day*ug/mL |
PK parameters for dstp3086s tab analytes in cycle 1 at 2.4 mg/kg.
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Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 313 | day*ug/mL |
PK parameters for dstp3086s tab analytes in cycle 1 at 2.4 mg/kg.
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Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 313 | day*ug/mL |
PK parameters for dstp3086s tab analytes in cycle 1 at 2.4 mg/kg.
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| Clearance (CL) | 8.3 | mL/day/kg |
PK parameters for dstp3086s tab analytes in cycle 1 at 2.4 mg/kg.
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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] | ||||
| Efficacy Data | Partial Response (PR) |
4%
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| Patients Enrolled |
Metastatic castration-resistant prostate cancer (CRPC).
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| Administration Dosage |
3 + 3 dose escalation study, 0.30 to 2.80 mg/kg intravenously given once every 3 weeks followed by cohort expansion at the recommended phase II dose or weekly (0.80 to 1.00 mg/kg).
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| Related Clinical Trial | |||||
| NCT Number | NCT01283373 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1, open-label study of the safety and pharmacokinetics of escalating doses of DSTP3086S in patients with metastatic castration-resistant prostate cancer. | ||||
| Primary Endpoint |
DsTP3086S has acceptable safety at the recommended phase II dose level of 2.40 mg/kg once every 3 weeks.
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| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT01283373 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1, open-label study of the safety and pharmacokinetics of escalating doses of DSTP3086S in patients with metastatic castration-resistant prostate cancer. | ||||
| Experiment 3 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible patients require metastatic castration-resistant prostate cancer (≤2 prior chemo regimens for expansion cohort), ECOG 0-2, and measurable disease. Key exclusions include recent anticancer therapy (4-week washout), active infections, uncontrolled CNS metastases (>8 weeks post-radiotherapy if treated), corticosteroids >10mg/day prednisone, or prior mAb hypersensitivity.
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| Administration Dosage |
This study evaluated safety and activity of DSTP3086S (0.3-2.8 mg/kg IV) given every 3 weeks (q3w) to pts with CRPC.
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| Related Clinical Trial | |||||
| NCT Number | NCT01283373 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I, Open-Label Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer | ||||
| Primary Endpoint |
Safety will be assessed through DLT monitoring during the first 21-day cycle to determine treatment tolerability.
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| Other Endpoint |
Comprehensive PK analyses including AUC, Cmax/Cmin, clearance, half-life, and volume of distribution will be conducted over a 1-year period to characterize drug exposure and metabolism.
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References