Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORIC-114 · 2 trials · 4 indications
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
PK of ORIC-114
PK of ORIC-114
PK of ORIC-114
PK of ORIC-114
| 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 |
| Dose Escalation and Dose Optimization | EXPERIMENTAL | ORIC-114 dosed orally on a continuous once daily dosing regimen in 28-day cycles. |
| Combination Dose Escalation | EXPERIMENTAL | ORIC-114 dosed orally on a continuous once daily dosing regimen in 21-day cycles. |
| 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 |
| ORIC-114 | DRUG | ORIC-114 oral daily |
| Chemotherapy drug | DRUG | 21 days for up to 4 cycles |
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 | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
ORIC-114 is an investigational small molecule being studied in adults with advanced solid tumors that harbor an EGFR or HER2 alteration. A second study evaluates it in combination with subcutaneous amivantamab in patients with EGFR Exon 20 insertion mutant non-small cell lung cancer. It has not been approved for any use.
ORIC-114 targets EGFR and HER2, two receptor tyrosine kinases whose alterations drive certain solid tumors. By binding these targets, the small molecule is designed to interfere with signaling that promotes tumor growth. Its clinical program enrolls patients whose tumors carry an EGFR or HER2 alteration, so the studies are biomarker selected.
ORIC-114 is being developed by Oric Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ORIC. The company sponsors both of the drug's active Phase 1 clinical studies, one as a single agent in EGFR or HER2 altered solid tumors and one in combination with subcutaneous amivantamab in EGFR Exon 20 insertion mutant NSCLC.
ORIC-114 is in Phase 1 clinical development. Both of its studies are Phase 1 and both are currently recruiting participants. The program has not completed any trials, and ORIC-114 is investigational, meaning it is not approved by the FDA or any other regulator for commercial use.
ORIC-114 is being evaluated in two recruiting Phase 1 trials. NCT05315700 studies ORIC-114 in patients with advanced solid tumors harboring an EGFR or HER2 alteration and plans to enroll 350 participants. NCT06816992 tests ORIC-114 with subcutaneous amivantamab in EGFR Exon 20 insertion mutant NSCLC and plans to enroll 76 participants.