NCT05005728

XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Xencor, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Metastatic Castration-Resistant Prostate Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	vudalimab + carboplatin + cabazitaxel	Vudalimab IV, carboplatin IV, cabazitaxel IV
COMBINATION_PRODUCT	vudalimab + olaparib	Vudalimab IV, olaparib oral
BIOLOGICAL	vudalimab monotherapy	Vudalimab IV
COMBINATION_PRODUCT	vudalimab + docetaxel	Vudalimab IV, docetaxel IV
COMBINATION_PRODUCT	vudalimab + cabazitaxel or docetaxel	Vudalimab IV, cabazitaxel or docetaxel IV

Timeline

• Start date: 2021-10-22
• Primary completion: 2025-06-10
• Completion: 2025-06-10
• First posted: 2021-08-13
• Last updated: 2025-07-17

Locations

26 sites across 1 country: United States

Regulatory

• FDA-regulated drug study