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ORIC-114 for Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by ORIC Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented EGFR or HER2 exon 20 insertion mutation or atypical EGFR mutation, or HER2 amplification/overexpression
ECOG performance status of 0 or 1
Must not have
Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
Known EGFR T790M mutation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests ORIC-114, a new oral medicine for advanced cancers. It targets proteins that help cancer grow, including in the brain, and is for patients who need new treatment options.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of ORIC-114 may include typical chemotherapy-related reactions such as nausea, fatigue, risk of infection due to low blood cell counts, hair loss, nerve damage causing numbness or tingling sensations in hands and feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has specific genetic changes in EGFR or HER2.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have NSCLC and have been treated with platinum-based chemotherapy or an alternative.
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My condition worsened after standard treatments, and I can't tolerate more of them.
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I agree to and can undergo a biopsy before treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had lung conditions that needed steroid treatment.
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My cancer has the EGFR T790M mutation.
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I do not have active gastrointestinal diseases like Crohn's, ulcerative colitis, or malabsorption syndromes.
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I do not have cancer spread to the lining of the brain or spinal cord compression.
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I have symptoms of HIV.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Apparent plasma terminal elimination half-life (t1/2)
Area under the curve (AUC)
Maximum plasma concentration (Cmax)
+2 more
Secondary study objectives
Clinical benefit rate (CBR)
Duration of response (DOR)
Intracranial progression-free survival (PFS)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Escalation and Dose OptimizationExperimental Treatment1 Intervention
ORIC-114 dosed orally on a continuous once daily dosing regimen in 28-day cycles.
Group II: Combination Dose EscalationExperimental Treatment2 Interventions
ORIC-114 dosed orally on a continuous once daily dosing regimen in 21-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chemotherapy drug
2020
N/A
~70
ORIC-114
2023
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

ORIC PharmaceuticalsLead Sponsor
7 Previous Clinical Trials
567 Total Patients Enrolled
Pratik S. Multani, MD, MSStudy DirectorORIC Pharmaceuticals
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

ORIC-114 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05315700 — Phase 1 & 2
Solid Tumors Research Study Groups: Dose Escalation and Dose Optimization, Combination Dose Escalation
Solid Tumors Clinical Trial 2023: ORIC-114 Highlights & Side Effects. Trial Name: NCT05315700 — Phase 1 & 2
ORIC-114 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05315700 — Phase 1 & 2
~30 spots leftby Mar 2025
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