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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 being studied for the treatment of colorectal cancer, as well as other malignancies that express carcinoembryonic antigen (CEA), including lung, breast, and prostate cancers. It is currently in Phase 1 clinical development.
Ad5 CEA Vaccine targets the carcinoembryonic antigen (CEA), a protein expressed on the surface of certain cancer cells. By targeting CEA, the vaccine is designed to stimulate the immune system to recognize and attack cancer cells that express this antigen.
Ad5 CEA Vaccine is being developed by ImmunityBio, Inc. (NASDAQ: IBRX). The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in patients with CEA-expressing malignancies.
Ad5 CEA Vaccine is in Phase 1 clinical development. It is an investigational agent and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the vaccine is not currently in active clinical trials.
Ad5 CEA Vaccine has been studied in one clinical trial, NCT01147965, titled 'QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA.' This Phase 1 trial enrolled 43 patients with colorectal, lung, breast, or prostate cancer and was conducted in the United States.
Ad5 CEA Vaccine is the investigational drug studied in the clinical trial known as QUILT-3.038, which has the National Clinical Trial number NCT01147965. QUILT-3.038 is the trial name, not an alternative name for the vaccine itself.