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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05707910 | Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 6 | — | — | Feb 8, 2023 | Dec 31, 2027 | Mar 9, 2026 | 1 | China |
The primary endpoint was safety, with adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
PFS is defined as the time from the administration of the first dose to first disease
OS is defined as the time from the administration of the first dose to death.
| Arm | Type | Description |
|---|---|---|
| Treatment Cohort | EXPERIMENTAL | EBV immunological agent administration on day 0,7,14,28 and 60 for subcutaneous injection. |
| Name | Type | Description |
|---|---|---|
| EBV immunological agent | BIOLOGICAL | 2\*10\^7 and 5\*10\^7 |
Inclusion Criteria: 1. Male or female patients: ≥ 18 years old; ≤ 70 years old; 2. Patients with EBV-positive advanced malignant tumors after failure of second-line standard therapy (including PD-1 inhibitor therapy); 3. ECOG physical fitness score: 0\~2 points; 4. Estimated survival ≥ 3 months; 5....