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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06816992 | ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC | PHASE1 | RECRUITING | 76 | — | — | Feb 27, 2025 | Dec 1, 2027 | Apr 24, 2026 | 4 | United States, Australia +1 |
RP2D of ORIC-114 in combination with amivantamab by interval 3+3 dose escalation design
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
| Arm | Type | Description |
|---|---|---|
| Part 1 Dose Escalation level 1 | EXPERIMENTAL | ORIC-114 + amivantamab |
| Part 1 Dose Escalation level 2 | EXPERIMENTAL | ORIC-114 + amivantamab |
| Part 1 Dose Escalation level 3 | EXPERIMENTAL | ORIC-114 + amivantamab |
| Part 2 Dose Expansion | EXPERIMENTAL | Two potential ORIC-114 dose levels + amivantamab |
| Name | Type | Description |
|---|---|---|
| ORIC-114 Dose 1 + amivantamab | DRUG | ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection |
| ORIC-114 Dose 2 + amivantamab | DRUG | ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection |
| ORIC-114 Dose 3 + amivantamab | DRUG | ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection |
Inclusion Criteria: * Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory * Pri...
| 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 |