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ORIC-114 EGFR or HER2 Advanced Solid Tumors - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Advanced Solid Tumor Cancers with EGFR or HER2 Mutations

Who Can Participate in the Study?

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 Group
Adults

What is Involved?

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.

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
Medical Oncologist
Protocol Number
IRB: PRO00115766
NCT: NCT05315700
Phase
Phase I/II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon