RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

This research is looking at a new drug called ORIC-114. It's for people with advanced solid tumours (cancers that form solid lumps) that have specific changes in their EGFR or HER2 genes. These gene changes can sometimes make cancer grow. The study aims to find the safest and most effective dose of ORIC-114, working out if it can shrink tumours. Researchers will test the drug on its own and possibly also together with standard chemotherapy. It's a 'first-in-human' study, meaning it's one of the first times this drug is being tested in people. They are particularly interested in finding a drug that can also reach tumours in the brain. The study is split into several parts, gradually increasing our understanding of the drug's effects.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

ORIC Pharmaceuticals

Enrolment target

350

Start

10 Mar 2022

Estimated completion

01 Sep 2027

Solid Tumors

What is this study about?

This study is investigating a new medication called ORIC-114, which has been designed to treat advanced solid tumours. These are cancers that have grown or spread. A key focus of this drug is to target specific changes, known as 'alterations' or 'mutations', in two genes called EGFR and HER2. When these genes behave differently than normal, they can encourage cancer to grow. ORIC-114 works by blocking the signals from these altered genes, which hopefully helps stop the cancer from growing.

The main goals of this study are to find the best and safest dose of ORIC-114, understand how it moves through the body, and see if it can shrink tumours. The researchers are particularly interested in whether the drug can reach and help tumours that have spread to the brain. This is important because many cancer treatments don't easily get into the brain.

The study is being carried out in different stages. Initially, it's exploring ORIC-114 on its own. Later, it might also look at combining ORIC-114 with a chemotherapy drug to see if that works better. The study is designed to gather comprehensive information about the drug's effects, starting with safety and then moving on to how effective it is for different types of cancer that have these specific EGFR or HER2 gene changes.

Key takeaways

New drug (ORIC-114) for advanced solid tumours.
Targets specific EGFR or HER2 gene changes.
Aims to find safest dose and check if tumours shrink.
May involve ORIC-114 alone or with chemotherapy.
Could help tumours that have spread to the brain.
Close medical monitoring if you take part.

Who may be eligible?

This study is for adults aged 18 or older who have advanced solid tumours. To be considered, your cancer must have specific changes in either the EGFR or HER2 gene. These changes will need to have been identified by a special test.

Initially, the study looked at a broad range of solid tumours with these gene changes, especially if you had already tried other standard treatments but they were no longer working well. Currently, the study is focusing on particular groups, including people with HER2-positive breast cancer, and certain types of lung cancer (NSCLC) with specific EGFR exon 20 insertion mutations.

Some parts of the study are for people who have already had standard treatments and a drug called amivantamab, while other parts are for people who haven't received previous treatment for their cancer. The doctors running the study will check all your medical details and test results to see if you meet the specific requirements for any of the ongoing parts.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have advanced solid tumour cancer?
Has your cancer been tested and found to have specific EGFR or HER2 gene changes?
Have you already tried other standard cancer treatments, or are they not suitable for you?
Are you able to take a medication orally (by mouth)?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to the hospital for various assessments. These assessments will include blood tests, scans (like CT scans) to check your tumour, and other tests to see how the study drug is affecting your body. You would take the study medication, ORIC-114, which is an oral treatment (a pill). The frequency of visits and tests would depend on the stage of the study and how your body reacts to the treatment. You would be closely monitored throughout your participation. The overall duration of your involvement would vary depending on how you respond to the treatment and the study's design. If the drug is helping, you might stay on it longer. We don't have specific details on the total number of visits or how long each visit might be, but the research team would explain this fully.

Potential risks and benefits

Participating in a clinical trial like this could offer some potential benefits. You would receive a new treatment, ORIC-114, which might help your cancer, especially if current standard treatments haven't worked or are no longer suitable for you. You would also be closely monitored by a dedicated medical team. However, with any new medication, there are potential risks. ORIC-114 might cause side effects, some of which could be serious. The medical team will explain all known side effects and monitor you carefully for any new ones. It's very important to remember that you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (42)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

City of Hope
Verified postcode
Duarte, United States· Recruiting
City of Hope
Verified postcode
Huntington Beach, United States· Recruiting
City of Hope
Verified postcode
Irvine, United States· Recruiting
City of Hope
Verified postcode
Long Beach, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
Yale Cancer Center
Verified postcode
New Haven, United States· Recruiting
Georgetown University
Verified postcode
Washington D.C., United States· Recruiting
Mayo Clinic
Verified postcode
Jacksonville, United States· Recruiting
Moffitt Cancer Center
Verified postcode
Tampa, United States· Recruiting
Northwestern University
Verified postcode
Chicago, United States· Recruiting
Dana Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Mayo Clinic
Verified postcode
Rochester, United States· Recruiting

Common questions

What is a 'solid tumour'?

A 'solid tumour' is a cancer that forms a solid mass or lump, as opposed to a blood cancer like leukaemia.

What are EGFR and HER2 alterations?

EGFR and HER2 are specific genes. Alterations (or mutations) in these genes can sometimes make cancer cells grow more quickly. The new drug aims to block these signals.

What does 'advanced' cancer mean?

Advanced cancer means the cancer has spread beyond where it started or has come back after previous treatment, and is no longer responding to standard therapies.

What is a 'Phase 1' or 'Phase 2' study?

Phase 1 studies primarily check if a new drug is safe and help find the best dose. Phase 2 studies then look more closely at how effective the drug is for the cancer being studied, using the dose found in Phase 1.

Will I get ORIC-114 or a dummy drug?

This study is 'open-label,' meaning everyone in the study will receive ORIC-114. There is no dummy drug (placebo) used in this specific trial.

How to find out more

ORIC Clinical

clinical@oricpharma.com 650-388-5600 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.