Study of ORIC-114 for Patients with Advanced Solid Tumors with EGFR or HER2 Changes

Sponsor: ORIC Pharmaceuticals

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05315700

Provider View

This clinical trial is testing a new drug, ORIC-114, to find the best dose and see how safe and effective it is for treating advanced solid tumors with specific genetic changes in EGFR or HER2.

Patient Parameters

Program Overview

The study aims to determine the best dose and safety of ORIC-114, a new drug designed to target specific genetic changes in EGFR and HER2, which are often found in advanced solid tumors. The trial will also explore how well the drug works alone or in combination with chemotherapy in shrinking tumors.

Description

ORIC-114 is a new drug that can reach the brain and is designed to target specific changes in the EGFR and HER2 genes, which are common in some advanced cancers. This study is the first time ORIC-114 is being tested in humans. It will start by testing the drug alone to find the best dose and see how well it works in patients whose cancer has these genetic changes and who have no other treatment options left. Once the best dose is found, the study will expand to include more patients with specific types of tumors to further test the drug's effectiveness. Additionally, the study may explore combining ORIC-114 with chemotherapy to see if this combination is safe and effective in treating these cancers.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced solid tumor with specific changes in EGFR or HER2 genes.
  • Have tried all available standard treatments without success or cannot tolerate them.
  • Be willing to have a biopsy before starting treatment.
  • Have measurable cancer that can be tracked.
  • If cancer has spread to the brain, it must be controlled or not causing symptoms.
  • Be in good overall health with a performance status of 0 or 1.
  • Have adequate organ function.

Exclusion Criteria

  • Have a specific EGFR T790M mutation.
  • Have cancer that has spread to the membranes around the brain and spinal cord, unless it is not causing symptoms.
  • Have severe heart problems or recent heart attack.
  • Have a history of lung disease that required steroid treatment.
  • Have active HIV infection or other serious infections.
  • Have digestive diseases that affect absorption of medication.
  • Have any other serious uncontrolled medical or psychological conditions.

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