Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0PLPNX
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| ADC Name |
SGN-ALPV
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| Synonyms |
SGN-ALPV
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| Organization |
Seagen (Top20 MNC) (Originator)
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| Drug Status |
Phase 1 (discontinued)
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
H12F3
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Antibody Info | Antigen Name | |||
| 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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| Cervical cancer |
1 Trials
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| Endometrial cancer |
1 Trials
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| Gastric cancer |
1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Lung cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Testicular 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) | 81.4±7.23 | ug/mL |
Pharmacokinetic parameters for SGN-ALPV after a single dose of 3 mg/kg in cynomolgus monkeys. (N=6)
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| Area Under the Concentration-Time Curve (AUC) | 188±17.9 | day*ug/mL |
Pharmacokinetic parameters for SGN-ALPV after a single dose of 3 mg/kg in cynomolgus monkeys. (N=6)
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Distribution
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 188±17.9 | day*ug/mL |
Pharmacokinetic parameters for SGN-ALPV after a single dose of 3 mg/kg in cynomolgus monkeys. (N=6)
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Metabolism
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 188±17.9 | day*ug/mL |
Pharmacokinetic parameters for SGN-ALPV after a single dose of 3 mg/kg in cynomolgus monkeys. (N=6)
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Excretion
| Standard Type | Value | Units | Description | Reference |
|---|---|---|---|---|
| Area Under the Concentration-Time Curve (AUC) | 188±17.9 | day*ug/mL |
Pharmacokinetic parameters for SGN-ALPV after a single dose of 3 mg/kg in cynomolgus monkeys. (N=6)
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General Information of The Activity Data Related to This ADC
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] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05229900 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 study of SGN-ALPV in advanced solid tumors. | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible participants must have specified advanced solid tumors (ovarian/endometrial/NSCLC/gastric/cervical/GCT cancers) with measurable disease (RECIST v1.1), ECOG 0-1, and biopsy compliance for biomarker analysis. Key exclusions include active CNS metastases, prior MMAE/ALPP-targeted therapy, or Grade≥2 neuropathy (CTCAE v5.0). Ovarian cancer cohorts require platinum-resistant HGSOC with prior bevacizumab exposure.
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| Administration Dosage |
.
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| Related Clinical Trial | |||||
| NCT Number | NCT05229900 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Study of SGN-ALPV in Advanced Solid Tumors | ||||
| Primary Endpoint |
Primary endpoints focus on safety evaluation including AE incidence (6 months post-treatment), DLT occurrence (28 days), and laboratory abnormalities, with dose-level toxicity analysis.
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| Other Endpoint |
Secondary objectives assess immunogenicity (ADA incidence over 6 months), PK parameters (AUC/Cmax/Tmax/t½/Ctrough within 14 days post-treatment), efficacy measures (ORR/DOR/PFS/OS per RECIST v1.1 over 2 years), and ovarian cancer-specific CA-125 responses (GCIG criteria).
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References
