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

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What is this study about?

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.

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Hospital Quironsalud Barcelona	Barcelona	Spain
Hospital Universitario Quironsalud Madrid	Pozuelo De Alarcon	Spain
Ukjokwfwamyzpr Ccbouvy Klcozrbue	Gdansk	Poland
Hxxaitgj Vaqc dmfwsdaw	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.10.2024
Spain	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Oric-114

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.

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.

Trial ID:

2024-512264-66-00

Protocol code:

ORIC-114-01

NCT ID:

NCT05315700

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?