Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01147965 | QUILT-3.038: Active Immunotherapy CEA Vaccine in Patients With Malignancies Expressing CEA | PHASE1 | COMPLETED | 43 | — | — | Jul 16, 2010 | May 31, 2017 | Nov 25, 2025 | 2 | United States |
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...