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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04710043 | Dose Escalation Trial of BNT152+153 in Patients With Cancer | PHASE1 | COMPLETED | 86 | — | — | Jun 8, 2021 | Sep 10, 2025 | Sep 25, 2025 | 7 | United States, Czechia |
TEAEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.
| Arm | Type | Description |
|---|---|---|
| Part 1 group A BNT153 | EXPERIMENTAL | Monotherapy dose escalation. |
| Part 1 group B BNT152 | EXPERIMENTAL | Monotherapy dose escalation. |
| Part 2A - BNT152+153 | EXPERIMENTAL | Escalating dose levels up to RP2D |
| Part 2B - BNT152+153 | EXPERIMENTAL | Escalating dose levels up to RP2D |
| Part 2C - BNT152+153 | EXPERIMENTAL | Escalating dose levels up to RP2D |
| Part 2 - BNT152+153 - biomarker cohort | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BNT152 | DRUG | intravenous |
| BNT153 | DRUG | intravenous |
Inclusion Criteria: * Histologically or cytologically confirmed solid tumor that is metastatic (Stage IV) or unresectable and for whom there is no available standard therapy likely to confer clinical benefit, or patient who is not a candidate for such available therapy. If there is no contraindicat...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab, V503, GARDASIL |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| AstraZeneca PLC | AZN | 1 | — | Trastuzumab deruxtecan |