General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0ERYUF
ADC Name
Felmetatug vedotin
Synonyms
felmetatug vedotin; SGN-B7H4V; PF-08046048
   Click to Show/Hide
Organization
Seagen (Top20 MNC) (Originator)
Drug Status
Phase 1 (discontinued)
Drug-to-Antibody Ratio
~4
Structure
Antibody Name
Felmetatug
 Antibody Info 
Antigen Name
V-set domain-containing T-cell activation inhibitor 1 (VTCN1)
 Antigen Info 
Payload Name
MMAE
 Payload Info 
Therapeutic Target
Microtubule (MT)
 Target Info 
Linker Name
Mc-Val-Cit-PABC
 Linker Info 
Conjugate Type
Random Cysteines
Combination Type
vedotin
Elimination
In kinetic analyses of this drug, it was found that over a 1-week span, 17% of the total administered MMAE was retrieved in feces and 6% in urine. This excretion primarily involved the unchanged drug. The mean clearance of enfortumab vedotin and free MMAE was 0.10 L/h and 2.7 L/h, respectively. The clearance of MMAE appears to be limited by its rate of release from enfortumab vedotin.
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
Biliary tract cancer
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
Breast cancer
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
Endometrial cancer
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
Fallopian tube cancer
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
Lung cancer
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
Ovarian cancer
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
Peritoneal cancer
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
Unspecific solid tumor
1 Trials
Trial ID
NCT05194072; EudraCT2023-503389-22; EUCT2023-503389-22-00
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Undisclosed  NCT05194072
Phase 1
A phase 1 study of SGN-B7H4V in advanced solid tumors.
Undisclosed  NCT05194072
PHASE1
A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 2 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Patients Enrolled
Locally advanced unresectable or metastatic solid tumors.
Administration Dosage
.
Related Clinical Trial
NCT Number NCT05194072  Clinical Status Phase 1
Clinical Description A phase 1 study of SGN-B7H4V in advanced solid tumors.
Experiment 2 Reporting the Activity Date of This ADC [2]
Patients Enrolled
Eligible participants have locally advanced/metastatic solid tumors (ovarian, breast, lung, etc.), ECOG 0-1, measurable disease (RECIST v1.1), and tumor tissue for analysis. Key exclusions: recent malignancies (≤3 years), active brain metastases (unless stable ≥4 weeks post-treatment), prior MMAE/B7-H4 therapy, Grade ≥2 neuropathy, or active corneal disease.

   Click to Show/Hide
Administration Dosage
.
Related Clinical Trial
NCT Number NCT05194072  Clinical Status PHASE1
Clinical Description A Phase 1 Study of SGN-B7H4V in Advanced Solid Tumors
Primary Endpoint
Safety will be assessed through AE monitoring up to 5 years post-treatment, including laboratory abnormalities and DLTs (within 28 days of dosing), with overall safety evaluated across dose levels.
Other Endpoint
Efficacy endpoints include confirmed ORR, CRR, DOR, PFS, and iDFS tracked up to 5 years per RECIST v1.1. PK parameters (AUC, Cmax, Tmax, t1/2, Ctrough) and ADA incidence will be analyzed descriptively over 3 years post-treatment.
References
Ref 1 First-in-human phase I study of ALT-P7, a HER2-targeting antibody-drug conjugate in patients with HER2-positive advanced breast cancer. J Clin Oncol. 2020 38:15_suppl, 3551-3551.
Ref 2 A Study of SGN-B7H4V in Advanced Solid Tumors