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Oric-114

ORIC-114 is an innovative drug currently being studied in clinical trials for its potential in treating advanced solid tumors and non-small cell lung cancer (NSCLC) with specific genetic alterations. This brain-penetrant, selective, orally bioavailable, irreversible small molecule inhibitor targets EGFR and HER2 mutations, offering hope for patients with limited treatment options, including those with brain metastases. The ongoing trials aim to establish the drug’s safety, effectiveness, and optimal dosing, both as a single agent and in combination with other treatments.

Table of Contents

What is ORIC-114?

ORIC-114 is a new drug currently being studied for its potential to treat advanced solid tumors. It is described as a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor. Let’s break down what this means:[1]

  • Brain penetrant: This means the drug can cross the blood-brain barrier and reach tumors in the brain.
  • Selective: It targets specific proteins in cancer cells, potentially reducing side effects on healthy cells.
  • Orally bioavailable: The drug can be taken by mouth and is effectively absorbed by the body.
  • Irreversible inhibitor: It permanently blocks certain proteins that cancer cells need to grow and survive.
  • Small molecule: This refers to the size of the drug, which allows it to easily enter cells.

How does ORIC-114 work?

ORIC-114 is designed to target specific alterations in two proteins: EGFR (Epidermal Growth Factor Receptor) and HER2 (Human Epidermal Growth Factor Receptor 2). These proteins are often overactive in certain types of cancer, causing uncontrolled cell growth. By inhibiting these proteins, ORIC-114 aims to slow down or stop the growth of cancer cells.[1]

What conditions does ORIC-114 treat?

ORIC-114 is being studied for the treatment of advanced solid tumors that have alterations in the EGFR or HER2 proteins. This could potentially include various types of cancer, such as:[1]

  • Lung cancer
  • Breast cancer
  • Colorectal cancer
  • Other solid tumors with EGFR or HER2 alterations

Importantly, ORIC-114 is being developed to treat patients whose cancer has spread to the brain (CNS metastases), which is often a challenging situation in cancer treatment.[1]

Clinical Trials and Research

ORIC-114 is currently being studied in clinical trials to determine its safety, effectiveness, and optimal dosing. Two main studies are underway:

  1. Food Effect Study: This study aims to understand how food affects the way the body processes ORIC-114. It involves healthy volunteers taking the drug with and without food to see if there are any differences in how the drug is absorbed and eliminated from the body.[2]
  2. Phase 1/2 Study in Cancer Patients: This larger study is testing ORIC-114 in patients with advanced solid tumors that have EGFR or HER2 alterations. The study has multiple parts:[1]
    • Part I: Determining the safe dose of ORIC-114 when used alone
    • Part II: Optimizing the dose and evaluating its effectiveness
    • Part III: Testing ORIC-114 in combination with chemotherapy (specifically, carboplatin and pemetrexed)

Administration and Dosing

ORIC-114 is taken orally (by mouth) once daily. The exact dose is still being determined through clinical trials. In the studies, it’s being given in cycles:[1][2]

  • When used alone, it’s given in 28-day cycles
  • When combined with chemotherapy, it’s given in 21-day cycles

The drug is currently being tested in tablet form, with doses ranging from 10 mg to higher amounts still being determined.[2]

Potential Side Effects

As ORIC-114 is still in clinical trials, the full range of potential side effects is not yet known. The ongoing studies are closely monitoring for any adverse effects. One of the secondary outcomes being measured is the number of participants experiencing treatment-emergent adverse effects, which will be assessed using a standardized scale called NCI CTCAE v5.0.[2]

Future Prospects

The development of ORIC-114 represents an exciting potential advance in cancer treatment, especially for patients with brain metastases. If successful, it could offer a new option for patients who have exhausted other available treatments. The ongoing clinical trials will provide crucial information about the drug’s effectiveness, safety, and optimal use.[1]

As research continues, more information will become available about ORIC-114’s potential benefits and risks. Patients interested in this treatment should discuss it with their oncologist to understand if it might be appropriate for their specific situation.

Aspect Details
Drug Name ORIC-114
Drug Type Brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor
Target EGFR and HER2 alterations
Cancer Types Advanced solid tumors, NSCLC with EGFR exon 20 insertion mutations
Administration Oral, daily
Combination Therapies Amivantamab, Chemotherapy (carboplatin and pemetrexed)
Key Study Objectives Establish RP2D, safety, PK, PD, antitumor activity
Notable Feature Potential efficacy against brain metastases

FAQ

  • What is ORIC-114 and how does it work? ORIC-114 is a brain-penetrant, selective, orally bioavailable, irreversible small molecule inhibitor. It is designed to target EGFR and HER2 alterations in cancer cells, making it a promising treatment for tumors with these genetic changes, including those that have spread to the brain.
  • What types of cancer is ORIC-114 being studied for? ORIC-114 is being studied for advanced solid tumors and non-small cell lung cancer (NSCLC) that have specific genetic alterations, particularly EGFR exon 20 insertion mutations and HER2 alterations.
  • How is ORIC-114 administered in clinical trials? In the clinical trials, ORIC-114 is administered orally on a daily basis. The exact dosage and schedule may vary depending on the specific trial and treatment phase.
  • Are there any combination therapies being tested with ORIC-114? Yes, some trials are exploring the combination of ORIC-114 with other treatments. For example, one study is investigating ORIC-114 in combination with amivantamab for NSCLC, while another is looking at combining it with chemotherapy (carboplatin and pemetrexed).
  • What are the main goals of the ORIC-114 clinical trials? The main goals of the ORIC-114 clinical trials include establishing the recommended Phase 2 dose (RP2D), assessing safety and side effects, studying how the drug behaves in the body (pharmacokinetics), and evaluating its effectiveness against tumors (antitumor activity).

Ongoing Clinical Trials on Oric-114

  • Study of ORIC-114 Alone or with Chemotherapy for Patients with Advanced Solid Tumors with EGFR or HER2 Alterations

    Recruiting

    2 1 1
    Investigated drugs:
    Poland Spain

Glossary

  • EGFR: Epidermal Growth Factor Receptor, a protein on the surface of cells that helps them grow and divide. Some cancer cells have too much EGFR, causing them to grow faster.
  • HER2: Human Epidermal growth factor Receptor 2, a gene that can play a role in the development of breast cancer when it is making too many copies of itself.
  • NSCLC: Non-Small Cell Lung Cancer, a type of lung cancer that is the most common form of the disease.
  • Exon 20 insertion mutation: A specific type of genetic change in the EGFR gene that can drive cancer growth, particularly in some lung cancers.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Pharmacodynamics (PD): The study of how a drug affects the body, including its mechanism of action and the relationship between drug concentration and effect.
  • CNS metastases: Cancer that has spread from its original location to the central nervous system, which includes the brain and spinal cord.
  • Recommended Phase 2 Dose (RP2D): The dose of a drug determined in early clinical trials to be appropriate for further testing in larger studies.
  • Maximum Tolerated Dose (MTD): The highest dose of a drug that does not cause unacceptable side effects.
  • Objective Response Rate (ORR): The proportion of patients whose cancer shrinks or disappears after treatment.
  • Progression-Free Survival (PFS): The length of time during and after treatment that a patient lives with cancer without it getting worse.
  • RECIST: Response Evaluation Criteria in Solid Tumors, a standard way to measure how well a cancer patient responds to treatment.

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