Purpose of this Study
We are doing this study to find out if an experimental drug called ORIC-114 (the study drug) is a safe and effective option for possible treatment in patients with advanced solid tumors harboring an EGFR or HER2 alteration.
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed with a locally advanced or metastatic solid tumor that has a documented mutation to the EFGR or HER2 genes.
For more information, contact the study team at annemarie.peters@duke.edu.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, your study regimen will depend on when you join the study.
Part 1 of the study is complete. This part of the study was done to figure out what dose range of the study drug seems to be most safe and effective.
If you join the study during Part 2, you will take either an 80 mg or 120 mg dose of the study drug. This part of the study is to find out which dose seems to be ideal.
If you join the study during Part 3, you will take the study in combination with other chemotherapy drugs to find out what dose of the study drug seems to be the best when it is combined with chemo medications.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination with Chemotherapy, in Patients with Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Principal Investigator
Laura
Alder
Protocol Number
PRO00115766
NCT ID
NCT05315700
Phase
I/II
Enrollment Status
Pending Open to Enrollment