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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05976828 | IBRX-042 In Participants With HPV-Associated Tumors | PHASE1 | ACTIVE NOT_RECRUITING | 12 | — | — | Jun 14, 2024 | Aug 14, 2033 | Oct 20, 2025 | 3 | United States |
The rate of DLTs will be assessed and the MTD determined
| Arm | Type | Description |
|---|---|---|
| First Dose Level | EXPERIMENTAL | Dose Cohort 1: IBRX -042 1e11 virus particles per dose |
| Second Dose Level | EXPERIMENTAL | Dose Cohort 2: IBRX-042 5e11 virus particles per dose |
| De-escalation Dose Level | EXPERIMENTAL | Dose Cohort -1: IBRX-042 5e10 virus particles per dose |
| Name | Type | Description |
|---|---|---|
| IBRX-042 | DRUG | * Dose cohort 1: 1e11 virus particles (VP)/dose * Dose cohort 2: 5e11 VP/dose * If needed, dose cohort -1 (de-escalation): 5e10 VP/dose |
Inclusion Criteria: 1. 18-75 years of age. 2. Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines. 3. Histologically confirmed HPV-associated cancer documented as HPV- or p16-positive c...