← Back to Search

Other

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

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

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 more
Secondary outcome measures
Clinical benefit rate (CBR)
Duration of response (DOR)
Intracranial progression-free survival (PFS)
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Escalation and Dose OptimizationExperimental Treatment1 Intervention
ORIC-114 dosed orally on a continuous daily dosing regimen in 28-day cycles.
Group II: Combination Dose EscalationExperimental Treatment2 Interventions
ORIC-114 dosed orally on a continuous 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

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned dose escalation as a medically acceptable practice?

"Our assessment at Power placed Dose Escalation's safety rating at 1, as the trial is only in phase one. This means that there is limited evidence of efficacy and safety from this medication."

Answered by AI

In how many locations is this exploration being conducted?

"4 medical centres are enrolment patients for this trial, such as University of California San Francisco in the Bay Area, Dana Farber Cancer Institute in Boston and Next Oncology based out of Fairfax. Additionally, there are 4 more sites accepting participants."

Answered by AI

Is admittance to this research project still accessible?

"Affirmative. Information presented on clinicaltrials.gov suggests that this medical experiment, which was originally advertised on March 10th 2022, is currently enrolling patients. A total of 42 participants need to be sourced from 4 separate sites."

Answered by AI

What are the essential goals of this medical experiment?

"This clinical trial will track a primary outcome over the course of 28 days - Time of maximum observed concentration (Tmax). Additionally, secondary outcomes such as Clinical benefit rate (CBR) and Objective response rate (ORR), both defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, along with Progression-free survival (PFS) determined similarly will be examined."

Answered by AI

What is the overall population size of participants in this experiment?

"ORIC Pharmaceuticals has identified a need for 42 patients to complete this medical trial. The study will be conducted out of different locations, including the University of California, San Francisco in San Francisco, Massachusetts and Dana Farber Cancer Institute in Boston, Virginia."

Answered by AI
~88 spots leftby Mar 2025