Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Aggression

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Carboplatin

Olaparib

Tubulin Modulators

Antimitotic Agents

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Vudalimab IV, carboplatin IV, cabazitaxel IV

vudalimab + carboplatin + cabazitaxel

vudalimab + olaparib

vudalimab monotherapy

vudalimab + docetaxel

Vudalimab IV, cabazitaxel or docetaxel IV

vudalimab + cabazitaxel or docetaxel

Jolene Shorr

Ginger Lee

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:

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

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

Xencor, Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer	NCT05005728	Metastatic Cast...	vudalimab + car... vudalimab + ola... vudalimab monot... vudalimab + doc... vudalimab + cab...	18 Years -	Xencor, Inc.
XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer	NCT05005728	Metastatic Cast...	vudalimab + car... vudalimab + ola... vudalimab monot... vudalimab + doc... vudalimab + cab...	18 Years -	Xencor, Inc.

Spots Global Cancer Trial Database for aggressive variant