Spots Global Cancer Trial Database for XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
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Trial Identification
Brief Title: XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer
Official Title: Phase 2 Multiple-Dose, Multiple-Arm, Parallel Assignment Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of XmAb®20717 Alone or in Combination With Chemotherapy or Targeted Therapies in Selected Subjects With Metastatic Castration-Resistant Prostate Cancer
Study ID: NCT05005728
Study Description
Brief Summary: This Phase 2 study will investigate the safety and clinical activity of vudalimab (XmAb20717) alone or in combination with standard of care anticancer therapies in patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed on prior therapy.
Detailed Description: Detailed Description: This is a Phase 2, open-label, multiple-dose, multiple-arm, parallel assignment study in patients with mCRPC who have progressed on prior therapy. It will enroll subjects into 1 of 5 molecularly defined cohorts based on the results of acceptable, documented prior diagnostic testing: * Cohort A: Aggressive variant prostate cancer (AVPCa) * Cohort B: Homologous recombination deficient (HRD)/cyclin-dependent kinase 12 (CDK12) biallelic loss tumors that have progressed on poly-adenosine diphosphate ribose polymerase inhibitors (HRD/CDK12 PARP Progressors) - Closed to Enrollment * Cohort C: HRD/CDK12 biallelic loss tumors, naive to PARP inhibitors (HRD/CDK12 PARP Naïve) - Closed to Enrollment * Cohort D: Microsatellite instability-high (MSI-H) or mismatch repair deficient (MMRD), or tumor mutational burden-high (TMB-H) tumors - Closed to Enrollment * Cohort E: No Targetable Mutations
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Mayo Clinic Hospital, Phoenix, Arizona, United States
City of Hope, Duarte, California, United States
VA Greater Los Angeles, Los Angeles, California, United States
University of California, San Diego, San Diego, California, United States
Mayo Clinic, Jacksonville, Florida, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
Mayo Clinic, Rochester, Minnesota, United States
GU Research Network/Urology Cancer Center, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Las Vegas, Nevada, United States
XCancer New Mexico Oncology Hematology Consultants, Ltd., Albuquerque, New Mexico, United States
Montefiore Medical Center, Bronx, New York, United States
Columbia University, New York, New York, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
University of Washington/Seattle Cancer Care/Alliance, Seattle, Washington, United States
Contact Details
Name: Jolene Shorr
Affiliation: Xencor, Inc.
Role: STUDY_DIRECTOR
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