IRB #

STUDY00021548

Title

A Phase 1, Multicenter, Open-label, Dose-Exploration and Dose-Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 650 in Subjects With Advanced Solid Tumors

Principal Investigator

Shivaani Kummar

Study Purpose

The purpose of the study is to learn more about AMG650 (from here on referred to as the study drug) in people with advanced solid tumor with a specific type of mutation. We are hoping to gather information on the safety and tolerability (good and bad effects) of the study drug.

Medical Condition(s)

Triple Negative Breast Cancer
Platinum-Resistant High Grade Serous Ovarian Cancer, primary peritoneal cancer and/or fallopian-tube cancer
Serous Endometrial Cancer
Advanced or metastatic solid tumor with TP53MUT (Dose Exploration only, as assessed by local testing)

Eligibility Criteria

1. Individuals 18 years or older
2. Adequate organ function
3. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

The length of your participation in this study will depend on how long you receive the study drug. For participants who completes the entire study from the date of informed consent through completion of safety follow-up or long term follow-up period, the duration of the study will be approximately 2 years to complete.

Minors Included

No

Contact

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

Sponsor

Amgen

Recruitment End

01/01/2022

Compensation Provided

No


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