Spots Global Cancer Trial Database for A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
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Trial Identification
Brief Title: A Study of FOR46 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Official Title: A Phase I Study of FOR46 Administered Every 21 Days in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)
Study ID: NCT03650491
Interventions
Study Description
Brief Summary: This study will test the safety and efficacy of FOR46 given every 21 days to patients with relapsed or refractory multiple myeloma. The name of the study drug involved in this study is: FOR46 for Injection
Detailed Description: This study is designed to evaluate the safety, tolerability and antitumor activity of FOR46 in patients with relapsed or refractory multiple myeloma. This study will be conducted in two parts: Dose escalation: This part will evaluate increasing doses of FOR46 to identify the maximum tolerated dose (MTD). The first patient enrolled on the study will receive the lowest dose of FOR46. Once this dose is shown to be safe, a second patient will be enrolled at the next higher dose. Patients will continue to be enrolled into either single or multiple patient groups receiving increasing doses until the MTD is reached. Dose expansion: This part of the study will further evaluate the safety, tolerability and antitumor activity of FOR46 at a dose shown to be safe in the dose escalation part of the study.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Washington University in St. Louis-Siteman Cancer Center, Saint Louis, Missouri, United States
Icahn School of Medicine at Mt. Sinai, New York, New York, United States
Contact Details
Name: Andrew Dorr, MD
Affiliation: Fortis Therapeutics, Inc.
Role: STUDY_DIRECTOR
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