ORIC-114 for Solid Tumors

Recruiting at 53 trial locations

Overseen By ORIC Clinical

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: ORIC Pharmaceuticals

Disqualifiers: EGFR T790M mutation, ILD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called ORIC-114 for individuals with advanced solid tumors, particularly those with specific genetic changes in EGFR or HER2. The trial seeks to determine the optimal dose and assess the safety and effectiveness of the treatment, both alone and in combination with chemotherapy. It is open to patients with conditions such as HER2-positive breast cancer or certain types of lung cancer who have not found success with other treatments. Participants must have measurable disease and stable or untreated brain involvement from cancer. This trial may suit those struggling with existing treatment options and who meet the specific genetic and health criteria. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ORIC-114 is likely to be safe for humans?

Studies have shown that ORIC-114 is generally safe, meaning most people can take the treatment without serious issues. In trials, researchers tested ORIC-114 on individuals with advanced solid tumors, focusing on its effects on tumors with changes in specific proteins called EGFR or HER2, which can influence cancer growth.

Early results suggest that ORIC-114 is usually well-tolerated at doses expected to be effective. While some side effects might occur, they are not usually severe. Although the study is still in its early stages, these findings are promising for those considering joining the trial. It is important to consult a doctor if interested in participating in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

ORIC-114 is unique because it targets solid tumors with a new approach. Unlike traditional treatments that might focus on chemotherapy or radiation, ORIC-114 is designed to be taken orally and works by inhibiting specific proteins involved in tumor growth. This targeted mechanism can potentially result in fewer side effects and offer a more precise attack on cancer cells. Researchers are excited about ORIC-114 because its continuous daily dosing regimen allows for consistent treatment, and it has the potential to work in combination with other therapies to enhance effectiveness.

What evidence suggests that ORIC-114 might be an effective treatment for solid tumors?

Research has shown that ORIC-114 could help treat advanced solid tumors with specific changes in the EGFR or HER2 genes. In early studies, patients with these gene changes responded well to the treatment. Specifically, initial results indicated that 81% of patients experienced some tumor reduction. This trial will explore ORIC-114 in two different dosing regimens: a dose escalation and dose optimization arm with 28-day cycles, and a combination dose escalation arm with 21-day cycles. The treatment is a daily pill, offering convenience for patients. Overall, these findings highlight ORIC-114's potential as a promising option for individuals with these types of tumors. ^{1 2 6 7 8}

Who Is on the Research Team?

Pratik S. Multani, MD, MS

Principal Investigator

ORIC Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors that have specific changes in genes called EGFR or HER2. Participants must have tried standard treatments without success and be able to undergo a biopsy. They should not have serious lung conditions, active gastrointestinal diseases, recent heart issues, known infections like hepatitis B or C, HIV, or any uncontrolled medical conditions.

Inclusion Criteria

My organs are functioning well.

My cancer has specific genetic changes in EGFR or HER2.

My brain involvement is either treated and stable or not treated but without symptoms.

Exclusion Criteria

I have an active infection needing treatment or a history of hepatitis B or C, but if I have hepatitis B, my virus levels are normal.

I have had lung conditions that needed steroid treatment.

My cancer has the EGFR T790M mutation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part I)

ORIC-114 is administered as a single agent to determine the recommended Phase 2 dose (RP2D) and maximum tolerated dose (MTD)

28 days

Continuous once daily dosing regimen

Dose Optimization (Part II)

Dose optimization to establish the RP2D and evaluate antitumor activity of ORIC-114

12 months

Combination Dose Escalation (Part III)

ORIC-114 is administered in combination with chemotherapy (carboplatin-pemetrexed) to establish the RP2D and/or MTD

21 days

Continuous once daily dosing regimen

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

What Are the Treatments Tested in This Trial?

Interventions

• ORIC-114

Trial Overview ORIC-114 is being tested either alone or with chemotherapy to find the safest and most effective dose for treating solid tumors with EGFR or HER2 alterations. The study will look at how well it works (its antitumor activity), its safety profile, and how the body processes it.

How Is the Trial Designed?

Group I: Dose Escalation and Dose Optimization Experimental Treatment 1 Intervention

ORIC-114 dosed orally on a continuous once daily dosing regimen in 28-day cycles.

Group II: Combination Dose Escalation Experimental Treatment 2 Interventions

ORIC-114 dosed orally on a continuous once daily dosing regimen in 21-day cycles.

Who Is Running the Clinical Trial?

ORIC Pharmaceuticals

Lead Sponsor

Trials

9

Recruited

970+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05315700

Study of ORIC-114 in Patients With Advanced Solid ... This is a first-in-human, open-label, single arm, multicenter, dose escalation study of ORIC-114 as a single agent (Part I), followed by dose optimization ( ...

2. investors.oricpharma.com investors.oricpharma.com/news-releases/news-release-details/initial-phase-1-dose-escalation-data-oric-114-patients-egfr-and

Initial Phase 1 Dose Escalation Data of ORIC-114 in Patients ... Initial Phase 1 Dose Escalation Data of ORIC-114 in Patients with EGFR and HER2 Exon 20 Mutations Demonstrates Potential Best-In-Class Profile · 81% were treated ...

3. oricpharma.com oricpharma.com/news/oric-pharmaceuticals-presented-preclinical-data-at-the-eortc-nci-aacr-international-conference-on-molecular-targets-and-cancer-therapeutics-supporting-best-in-class-potential-of-oric-944-to-trea/

ORIC Pharmaceuticals ORIC-944 combined with the KRAS inhibitor adagrasib, regressed 100% of tumors in KRAS-mutant adenocarcinoma and squamous NSCLC xenograft models ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20571435

Study of ORIC-114 in Patients With Advanced Solid ... The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK) ...

5. tipranks.com tipranks.com/news/company-announcements/oric-pharmaceuticals-promising-study-on-oric-114-for-solid-tumors

Oric Pharmaceuticals' Promising Study on ORIC-114 for ... ' The study aims to determine the recommended Phase 2 dose, evaluate safety, and assess the antitumor activity of ORIC-114 in patients with ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(23)03203-9/fulltext

1333P A global phase 1b study of ORIC-114, a highly ... ORIC-114 has demonstrated an acceptable safety profile and preliminary antitumor activity, including in the CNS, at doses predicted to be active. Enrollment is ...

7. oricpharma.com oricpharma.com/news/oric-pharmaceuticals-announces-clinical-supply-agreement-to-evaluate-oric-114-in-combination-with-amivantamab-for-the-first-line-treatment-of-nsclc-with-egfr-exon-20-insertion-mutations/

Phase 1b combination trial of ORIC-114 and ... The company expects to report initial data from the trial in mid-2026. In 2024, the company announced the completion of the monotherapy dose ...

8. investors.oricpharma.com investors.oricpharma.com/news-releases/news-release-details/oric-pharmaceuticals-announces-first-patients-dosed-across-three

ORIC Pharmaceuticals Announces First Patients Dosed ... The Phase 1b expansion portion of the trial will evaluate the safety and efficacy of ORIC-114 at the provisional RP2D levels of 80 mg and 120 mg QD in patients ...