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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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Dose Escalation and Dose Optimization
- Group 2: Combination Dose Escalation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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