Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0QQSDO
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| ADC Name |
Fetrastobart vedotin
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| Synonyms |
PF-08046054; SGN-PDL1V
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| Organization |
Seagen (Top20 MNC) (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
4
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| Structure |
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| Antibody Name |
Anti-PD-L1 SGN-PDL1V mAb
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Antibody Info | ||||
| Antigen Name |
Myeloid cell surface antigen CD33 (CD33); Programmed cell death 1 ligand 1 (CD274)
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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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| Breast cancer |
1 Trials
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| Endometrial cancer |
1 Trials
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| Gastric cancer |
1 Trials
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| Head and neck cancer |
1 Trials
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| Liver cancer |
1 Trials
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| Lung cancer |
1 Trials
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1 Trials
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| Oesophageal cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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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 | [1] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05208762 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 study of SGN-PDL1V in advanced solid tumors. | ||||
| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
27.30%
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| Patients Enrolled |
Key exclusions were active CNS metastases (except stable treated ones 4 weeks prior), prior anti-PD-L1 within 5 half-lives, MMAE-containing agent exposure, or ≥Grade 2 neuropathy per NCI CTCAE v5.0. Stratification occurred by tumor type (Parts A-E) and PD-L1 status.
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| Administration Dosage |
In dose escalation, pts received doses of SGN-PDL1V from 0.5-1.75 mg/kg on days 1, and 8 of every 21-day cycle using adjusted ideal body weight. The primary objectives of this study are safety/tolerability and pharmacokinetics with antitumor activity as a secondary objective.
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| Related Clinical Trial | |||||
| NCT Number | NCT05208762 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Study of SGN-PDL1V in Advanced Solid Tumors | ||||
| Primary Endpoint |
Safety evaluations included AE monitoring for up to 3 years, with specific focus on DLTs during the first treatment cycle, laboratory abnormalities, and immunogenicity (ADA incidence). PK parameters (AUC, Cmax, Ctrough) were assessed until last treatment plus 30-37 days.
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| Other Endpoint |
Efficacy outcomes measured confirmed ORR, DOR, PFS, and OS per RECIST v1.1 over ~3 years across multiple solid tumors (NSCLC, HNSCC, TNBC, etc.), requiring PD-L1 expression (TPS/CPS ≥1 or <1) and prior therapy failure/refusal.
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References
