Product Description
SGT-53 is a complex composed of a wild type p53 gene (plasmid DNA) encapsulated in a liposome that is targeted to tumor cells by means of an anti-transferrin receptor single-chain antibody fragment (TfRscFv) attached to the outside of the liposome. Pre-clinical studies have indicated that SGT-53 could sensitize tumors to the effects of radiation/chemotherapy. (Sourced from: https://clinicaltrials.gov/ct2/show/NCT00470613)
Mechanisms of Action: Gene Therapy
Novel Mechanism: No
Modality: Gene Therapy
Route of Administration: Intravenous
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Amgen
Company Location: THOUSAND OAKS CA 91320
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Glioblastoma|Pancreatic Cancer
Phase 1: Inflammatory Breast Cancer|Triple Negative Breast Cancer|Oncology Unspecified|Medulloblastoma|Oncology Solid Tumor Unspecified|Ependymoma|Glioma|Pinealoma|Liver Cancer|Bone Cancer|Rhabdomyosarcoma
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07017816 |
JACOB | P1 |
Not yet recruiting |
Pinealoma|Medulloblastoma|Glioma|Ependymoma |
2028-05-01 |
2025-06-13 |
Primary Endpoints|Treatments |
|
NCT02354547 |
SGT53-01-2 | P1 |
Suspended |
Liver Cancer|Rhabdomyosarcoma|Bone Cancer |
2025-12-01 |
50% |
2025-05-31 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT03554707 |
SGT53-00-1 | P1 |
Unknown status |
Oncology Unspecified |
2023-12-01 |
12% |
2024-12-03 |
Primary Endpoints|Treatments|Trial Status |
NCT05093387 |
NU 19B07 | P1 |
Withdrawn |
Triple Negative Breast Cancer|Inflammatory Breast Cancer |
2022-11-10 |
2022-11-16 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT00470613 |
SGT53-01 | P1 |
Completed |
Oncology Solid Tumor Unspecified |
2016-12-01 |
2019-03-21 |
Treatments |
|
NCT02340117 |
SGT53-02-1 | P2 |
Active, not recruiting |
Pancreatic Cancer |
2026-12-01 |
12% |
2025-05-31 |
Primary Endpoints |
NCT02340156 |
SGT53-02-2 | P2 |
Terminated |
Glioblastoma |
2018-11-01 |
2020-03-19 |
Patient Enrollment|Primary Endpoints|Treatments |