Spots Global Cancer Trial Database for Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Testing the Effect of M1774 on Hard-to-Treat Refractory SPOP-mutant Prostate Cancer
Official Title: A Phase 2 Study of M1774 in Refractory SPOP-Mutant Prostate Cancer
Study ID: NCT05828082
Conditions
Study Description
Brief Summary: This phase II trial tests how well M1774 works in treating patients with prostate cancer that does not respond to treatment (refractory) and that has a mutation in the gene responsible for making the speckle type BTB/POZ protein (SPOP). M1774 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving M1774 may be able to shrink or stabilize refractory SPOP-mutant prostate cancer.
Detailed Description: PRIMARY OBJECTIVE: I. To evaluate the response rate of tuvusertib (ATR inhibitor M1774) in highly refractory prostate cancer. SECONDARY OBJECTIVES: I. To evaluate the overall survival (OS) of refractory SPOP-mutant prostate cancer patients receiving tuvusertib (M1774). II. To evaluate the progression-free survival (PFS) of refractory SPOP-mutant prostate cancer patients receiving M1774. III. To evaluate the Common Terminology Criteria for Adverse Events (CTCAE) 5.0-defined adverse event (AE) rates of refractory SPOP-mutant prostate cancer patients receiving M1774. EXPLORATORY OBJECTIVE: I. To determine changes in SPOP-mutant circulating tumor deoxyribonucleic acid (ctDNA) and SPOP-, ATR-, and ATM-related gene signature changes on ATR inhibition, including RAC1, FDFT1, DHCR24, DHCR7, and MVD. OUTLINE: Patients receive tuvusertib orally (PO) every day (QD) on days 1-14. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo biopsy, magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET)/MRI, PET/CT or ultrasound (U/S) and collection of blood samples throughout the trial. After completion of study treatment, patients are followed up every 6 months for 2 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center, Miami, Florida, United States
Memorial Hospital East, Shiloh, Illinois, United States
University of Kansas Cancer Center, Kansas City, Kansas, United States
University of Kansas Hospital-Indian Creek Campus, Overland Park, Kansas, United States
University of Kansas Hospital-Westwood Cancer Center, Westwood, Kansas, United States
Dana-Farber - Harvard Cancer Center LAO, Boston, Massachusetts, United States
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Siteman Cancer Center at West County Hospital, Creve Coeur, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Siteman Cancer Center-South County, Saint Louis, Missouri, United States
Siteman Cancer Center at Christian Hospital, Saint Louis, Missouri, United States
Siteman Cancer Center at Saint Peters Hospital, Saint Peters, Missouri, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
UT Southwestern Simmons Cancer Center - RedBird, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Dallas, Dallas, Texas, United States
UT Southwestern/Simmons Cancer Center-Fort Worth, Fort Worth, Texas, United States
UT Southwestern Clinical Center at Richardson/Plano, Richardson, Texas, United States
University of Virginia Cancer Center, Charlottesville, Virginia, United States
University of Wisconsin Carbone Cancer Center - University Hospital, Madison, Wisconsin, United States
Contact Details
Name: Jacob Orme
Affiliation: Dana-Farber - Harvard Cancer Center LAO
Role: PRINCIPAL_INVESTIGATOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
