IRB #

STUDY00022580

Title

CRESTONE: A Phase 2 Study of Seribantumab in Adult Patients with Neuregulin-1 (NRG1) Fusion Positive Locally Advanced or Metastatic Solid Tumors

Principal Investigator

Shivaani Kummar

Study Purpose

The purpose of the study is to learn more about the study drug, seribantumab, in people with advanced or metastatic cancer that is believed to be caused by a change in the NRG1 gene called a fusion. The study is hoping to find out how well the NRG1 gene fusion positive cancer responds to the administration of the study drug. The study is also hoping to gather information on the safety and tolerability (good and bad effects) of the study drug.

Medical Condition(s)

Locally-advanced or metastatic solid tumor with an NRG1 gene fusion

Eligibility Criteria

1. Individuals that are 18 years of age or older.
2. Adequate organ function
3. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

The amount of time you will participate on the study will depend on how you respond to the study drug. You may receive study drug as long as you continue to benefit. You may continue to receive the study drug until you decide to stop, develop an intolerable side effect, or the investigator believes it is better for you to stop receiving the study drug. Overall, you should expect to be on treatment for at least six months or longer. After you stop receiving the study drug, the sponsor will continue to collect health information to evaluate the study drug’s long-term effects.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Elevation oncology Inc.

Recruitment End

05/01/2022

Compensation Provided

No


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