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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trialtests a new drug to treat advanced solid tumors with EGFR/HER2 alterations, to find a safe dose and how it works in the body.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Apparent plasma terminal elimination half-life (t1/2)
Area under the curve (AUC)
Maximum plasma concentration (Cmax)
+2 moreSecondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Intracranial progression-free survival (PFS)
+3 moreTrial 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
359 Total Patients Enrolled
Pratik S. Multani, MD, MSStudy DirectorORIC Pharmaceuticals
1 Previous Clinical Trials
1 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My organs are functioning well.My cancer has specific genetic changes in EGFR or HER2.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.My brain involvement is either treated and stable or not treated but without symptoms.I have had lung conditions that needed steroid treatment.My cancer has the EGFR T790M mutation.I do not have active gastrointestinal diseases like Crohn's, ulcerative colitis, or malabsorption syndromes.I am fully active or restricted in physically strenuous activity but can do light work.I do not have cancer spread to the lining of the brain or spinal cord compression.I have symptoms of HIV.I have NSCLC and have been treated with platinum-based chemotherapy or an alternative.My condition worsened after standard treatments, and I can't tolerate more of them.I agree to and can undergo a biopsy before treatment.I have had multiple treatments for my condition.I have not had severe heart issues like heart failure or heart attack in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation and Dose Optimization
- Group 2: Combination Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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