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Spots Global Cancer Trial Database for Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors

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Trial Identification

Brief Title: Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors

Official Title: A Phase 1, Multicenter, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects With Advanced Solid Tumors

Study ID: NCT04727554

Interventions

AMG 994
AMG 404

Study Description

Brief Summary: The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.

Detailed Description: AMG 994 will be administered by short term intravenous (IV) infusion once weekly in each 28-day cycle and AMG 404 will be administered by short-term IV infusion once every 4 weeks (Q4W) in a 28 day cycle (on day 1 of cycle 2 and beyond). The study will be conducted in 2 parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope National Medical Center, Duarte, California, United States

Henry Ford Hospital, Henry Ford Health Systems, Detroit, Michigan, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Sarah Cannon Research Institute, Nashville, Tennessee, United States

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Monash Medical Centre, Clayton, Victoria, Australia

Linear Clinical Research Limited, Nedlands, Western Australia, Australia

Universitair Ziekenhuis Gent, Gent, , Belgium

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Centre Leon Berard, Lyon, , France

Universitatsklinikum Ulm, Ulm, , Germany

Universitätsklinikum Würzburg, Würzburg, , Germany

National Cancer Center Hospital East, Kashiwa-shi, Chiba, Japan

National Hospital Organization Shikoku Cancer Center, Matsuyama-shi, Ehime, Japan

Narodowy Instytut Onkologii im Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Warszawa, , Poland

Hospital Universitari Vall d Hebron, Barcelona, Cataluña, Spain

University College London Hospital, London, , United Kingdom

Contact Details

Name: MD

Affiliation: Amgen

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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