Recruiting

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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment called ORIC-114 in patients with advanced solid tumors. Solid tumors are abnormal masses of tissue that can occur in various parts of the body. The study is particularly interested in tumors that have specific changes in genes known as EGFR or HER2. These genetic changes can affect how cancer cells grow and respond to treatment.

The purpose of the study is to evaluate the safety and how well patients tolerate ORIC-114 when used alone or in combination with chemotherapy drugs like carboplatin and pemetrexed. The study will also look at how the body processes the drug, which is known as pharmacokinetics. Participants will take ORIC-114 in the form of a tablet, and the study will be conducted in different parts to determine the best dose for future research.

Throughout the study, participants will receive regular assessments to monitor their health and any side effects. These assessments will include checking vital signs, conducting laboratory tests, and performing heart tests like an ECG. The study will also measure how the tumors respond to the treatment over time. This information will help researchers understand the potential benefits and risks of ORIC-114 for treating advanced solid tumors with EGFR or HER2 alterations.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, ability to swallow medication, and health status.
A negative pregnancy test is required for women of childbearing potential before starting the treatment.
Informed consent is obtained, and agreement to comply with study requirements is necessary.
Step 2
Initial treatment phase
The study involves taking ORIC-114, which is a tablet taken orally.
The initial phase assesses the safety and tolerability of ORIC-114 as a single agent.
Regular monitoring of health status, including vital signs and laboratory tests, is conducted.
Step 3
Dose determination
The optimal dose of ORIC-114 is determined for further study phases.
This involves evaluating the body's response to the medication and adjusting the dose as needed.
Step 4
Combination treatment phase
In this phase, ORIC-114 is combined with chemotherapy drugs carboplatin and pemetrexed.
The safety and tolerability of this combination are assessed.
Regular assessments are conducted to monitor any side effects or changes in health status.
Step 5
Ongoing assessments
Throughout the study, regular assessments are conducted to evaluate the effectiveness of the treatment.
This includes imaging tests to monitor tumor response and progression.
The study aims to measure the duration of response and progression-free survival.
Step 6
Study completion
The study is estimated to end by March 2026.
Upon completion, final assessments are conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

13 criteria

You must be **18 years or older** at the time of signing the consent form.
You need to be able to **swallow pills** without chewing or crushing them.
If you are a woman who can have children, you must have a **negative pregnancy test** within 72 hours before starting the study treatment.
If you are a woman who can have children or a man who is not surgically sterile, you must agree to use a **highly effective birth control method** during the study and for 90 days after the treatment ends.
You must be willing and able to **give informed consent** and follow the study requirements for its duration.
You must have a **confirmed solid tumor** that is locally advanced or has spread to other parts of the body, with a specific type of genetic mutation called **EGFR or HER2 exon 20 insertion mutation** or an **atypical EGFR mutation**.
You must have had **prior treatments** as described in the study protocol.
You must agree and be able to have a **biopsy** before treatment, if it is safe and possible according to the study doctor.
You must have a **measurable disease** according to specific guidelines called **RECIST 1.1**.
If you have **CNS involvement** (meaning the cancer has affected your brain or spinal cord), it must be either previously treated and controlled or untreated and not causing symptoms.
If you have another cancer, it must not interfere with the safety or effectiveness of the study drug.
You must have an **ECOG performance status** of 0 or 1, which means you are fully active or have some symptoms but can still carry out light work.
You must have **adequate organ function** as defined by the study criteria.

Who cannot join the trial?

4 criteria

Patients with certain types of cancer called solid tumors are the focus of this study.
Both men and women can participate in the study.
People of all ages, including children and adults, are eligible.
Individuals who are considered part of a vulnerable population, which means they might need special protection or care, are not included in this study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Universitario Quironsalud Madrid
Verified
Pozuelo De Alarcon, Spain
Hospital Vall d’Hebron
Verified
Barcelona, Spain
Uniwersyteckie Centrum Kliniczne
Verified
Gdansk, Poland

Trial locations

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Investigated drugs

ORIC-114
is an investigational medication being studied for its potential to treat advanced solid tumors that have specific changes in the EGFR or HER2 genes. The study aims to understand how safe and tolerable ORIC-114 is when used alone and to determine the best dose for further research. Additionally, the study will explore how the body processes ORIC-114.
Carboplatin
is a chemotherapy drug used in combination with other medications to treat various types of cancer. In this study, it is combined with ORIC-114 to evaluate the safety and effectiveness of this combination in treating advanced solid tumors.
Pemetrexed
is another chemotherapy medication that is used to treat certain types of cancer, often in combination with other drugs. In this trial, it is used alongside ORIC-114 and carboplatin to assess the safety and potential benefits of this treatment combination for patients with advanced solid tumors.

Oric-114

What is already known about the treatment

ORIC-114 – ORIC-114 is an investigational medication currently being studied in clinical trials for its potential use in treating advanced solid tumors with specific genetic alterations in EGFR or HER2. It is administered orally, allowing for convenient dosing. The medication is in the early stages of clinical research, with ongoing studies assessing its safety, tolerability, and optimal dosing. ORIC-114 works by targeting and inhibiting specific proteins involved in tumor growth and survival, classified as a targeted therapy. Its main therapeutic indication is for patients with solid tumors that have specific genetic changes, aiming to provide a more personalized treatment approach.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they grow, they may press on nearby organs and tissues, potentially affecting their function. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to invade nearby tissues and spread to distant sites. The progression of solid tumors depends on their type, location, and other factors, influencing how they impact the body.