IRB #

STUDY00022902

Title

A Phase 2, Subprotocol of DAY101 Monotherapy for Patients with Recurrent, Progressive, or Refractory Solid Tumors with MAPK Pathway Aberrations

Principal Investigator

Shivaani Kummar

Study Purpose

The purpose of the study is to test the efficacy and safety of the study drug (Day 101) when given alone for solid tumors with an abnormality in the specific protein called BRAF or in the specific protein called CRAF/RAF1 (CRAF/RAF1 fusion or amplification) in adolescent and adult participants. OHSU will only be enrolling adult participants.

Medical Condition(s)

Solid tumors with an abnormality in the specific protein called BRAF or in the specific protein called CRAF/RAF1 in adult participants.

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. After you stop receiving the study drug, the sponsor will continue to collect health information to evaluate the study drug’s long-term effects. The estimated total duration of this study is expected to be about 4 years.

Minors Included

No

Contact

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

Sponsor

DOT Therapeutics-1 Inc. (“Day One”)

Recruitment End

01/01/2023

Compensation Provided

No


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