Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ORIC-114 · 2 trials · 2 indications
To evaluate the effect of food on the single dose PK of ORIC-114 tablet formulation
Food Effect: PK of ORIC-114 tablet
Food Effect: PK of ORIC-114 tablet
Food Effect: PK of ORIC-114 tablet
RP2D as determined by interval 3+3 dose escalation design
| Arm | Type | Description |
|---|---|---|
| Part 1 Treatment A | EXPERIMENTAL | 30 mg ORIC-114 (3 x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. |
| Part 1 Treatment B | EXPERIMENTAL | 30 mg ORIC 114 (3 x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal. |
| Part 2 Treatment A | EXPERIMENTAL | xx mg ORIC-114 (n x 10 mg tablets) administered at Hour 0 on Day 1 under fasting conditions. |
| Part 2 Treatment B | EXPERIMENTAL | xx mg ORIC 114 (n x 10 mg tablets) administered at Hour 0 on Day 1, 30 minutes after the start of a meal. |
| 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 | DRUG | Food effect healthy subjects |
| Chemotherapy drug | DRUG | 21 days for up to 4 cycles |
Inclusion Criteria: 1. Healthy, adult, male or female (of nonchildbearing potential only), 18-55 years of age 2. Continuous nonsmoker who has not used nicotine and tobacco containing products for at least 30 days 3. Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 4. Medically healthy with no clinical...
ORIC-114 is an investigational small molecule being studied for the treatment of advanced solid tumors harboring an EGFR or HER2 alteration. It is also being evaluated in a food effect study in healthy participants to understand how food affects its pharmacokinetics.
ORIC-114 targets cancers with EGFR or HER2 alterations. It is being studied in patients with advanced solid tumors that have these specific genetic changes, as part of a Phase 1 clinical trial.
ORIC-114 is being developed by Oric Pharmaceuticals, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.
ORIC-114 is in Phase 1 clinical development. It is being studied in an ongoing Phase 1 trial for advanced solid tumors with EGFR or HER2 alterations, and a Phase 1 food effect study in healthy participants has been completed.
ORIC-114 is being studied in two Phase 1 trials. NCT05315700 is recruiting patients with advanced solid tumors harboring EGFR or HER2 alterations, and NCT06012721, a food effect study in healthy participants, has been completed.
ORIC-114 is the drug name used in clinical trials. No alternative names have been reported for this investigational agent.