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Ad5 CEA Vaccine · 1 trial · 4 indications
The primary objective of this protocol is to determine the safety of immunization with Ad5 \[E1-, E2b-\]-CEA(6D) in patients with advanced or metastatic CEA-expressing malignancies. A dosing scheme will be considered safe if \<33% of patients treated at a dosage level experience DLT (e.g., 0 of 3, ≤1 of 6, ≤3 of 12 or ≤5 of 18 patients).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^9 particles |
| Cohort 2 | EXPERIMENTAL | Cohort 2: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^10 particles |
| Cohort 3 | EXPERIMENTAL | Cohort 3: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles |
| Cohort 4 | EXPERIMENTAL | Cohort 4 (Phase II Cohort at MTD): Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 1 x 10\^11 particles |
| Cohort 5 | EXPERIMENTAL | Cohort 5: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 5 x 10\^11 particles |
| Cohort 6 | EXPERIMENTAL | Cohort 6: Ad5 \[E1-, E2b-\]-CEA(6D) at a dose of 5 x 10\^11 particles |
| Name | Type | Description |
|---|---|---|
| Ad5 CEA Vaccine | BIOLOGICAL | Ad5 \[E1-, E2b-\]-CEA(6D) Vector Vaccine |
Inclusion Criteria 1. Histologically confirmed diagnosis of malignancy expressing CEA. Because this is a safety and immunogenicity study, patients are NOT required to have measurable or evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST). 2. For all tumor types other than col...
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Ad5 CEA Vaccine is an investigational active immunotherapy vaccine developed by ImmunityBio, Inc. for cancers that express carcinoembryonic antigen (CEA). It was studied in a Phase 1 trial in patients with colorectal cancer and other CEA-expressing malignancies. It is not an approved therapy and remains in clinical development.
Ad5 CEA Vaccine is being studied as a treatment for colorectal cancer that expresses the CEA protein. It is an active immunotherapy designed to stimulate an immune response against CEA-expressing tumor cells. The vaccine has been tested in a Phase 1 clinical trial and is not yet approved for any indication.
Ad5 CEA Vaccine is developed by ImmunityBio, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol IBRX. ImmunityBio is responsible for the clinical development of the vaccine.
Ad5 CEA Vaccine is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. The vaccine is investigational and has not been approved by the FDA for any indication.
Ad5 CEA Vaccine has been evaluated in one completed Phase 1 trial, NCT01147965, titled QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA. The trial enrolled 43 patients in the United States with colorectal, lung, breast, or prostate cancer.