Phase 1/2 Study of ORIC-114

• Research type

  Research Study

• Full title

  An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination with Chemotherapy, in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

• IRAS ID

  1010011

• Contact name

  Jennifer Shen

• Contact email

  jennifer.shen@oricpharma.com

• Sponsor organisation

  ORIC Pharmaceuticals, Inc.

• Eudract number

  2024-512264-66

• Clinicaltrials.gov Identifier

  NCT05315700

• Research summary

  This research study is testing an experimental (investigational) drug called ORIC-114 (also referred to as the “study drug”) that is being studied as a possible treatment for advanced cancers that are no longer responding to available treatments.
  This is a first-in-human study of ORIC-114. In animal studies ORIC-114 has shown antitumour activity, specifically inhibiting certain proteins that are involved with the growth of cancer cells. It is hypothesised based on this information that ORIC-114 may be a treatment option for patients with advanced solid tumours that have DNA mistakes or damages in the Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) genes that make these proteins and are no longer responding to the standard available treatments.
  The research study consists of three parts:
  • Part I: is the dose finding portion for ORIC-114 when administered as a single drug. This part of the study is complete
  • Part II: will further test two active doses of 120 mg and 80 mg administer once daily which were selected from Part I (shown to have antitumour effect) to select the most tolerable and safe active dose
  • Part III: is the dose finding portion for ORIC-114 when administered in combination with chemotherapy and will enrol patients only in the US

  There will also be three Part I extension groups:
  Group IA: will enrol breast cancer patients who have a mutation in the HER2 gene
  Group IB: will enrol Non-Small Cell Lung Cancer (NSCLC) patients who have a mutation in the EGFR gene and have been previously treated with chemotherapy and amivantamab
  Group IC will enrol NSCLC patients who have a mutation in the EGFR gene and have not been previously treated.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  24/LO/0488

• Date of REC Opinion

  6 Aug 2024

• REC opinion

  Further Information Favourable Opinion