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

NCT05005728 | Completed Phase 2 FDA Drug

• 1 other identifier: XmAb20717-04
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 26

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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Keywords

Prostate cancer; Metastatic castration resistant; Aggressive variant; Anaplastic; Neuroendocrine; Homologous recombination deficiency; MSI-H; CDK12; XmAb20717; Vudalimab

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (safety and tolerability of vudalimab)

  8 weeks

Secondary Outcomes (5)

• Objective response rate (RECIST 1.1, as modified by PCWG3)

  8 weeks

• Prostate-specific antigen (PSA) response

  8 weeks

• Bone scans based on PCWG3 criteria

  8 weeks

• Radiographic progression-free survival (PCWG3)

  8 weeks

• Duration of response (RECIST 1.1, as modified by PCWG3)

  8 weeks

Study Arms (5)

Cohort A - AVPCa

EXPERIMENTAL

Combination Product: vudalimab + carboplatin + cabazitaxel

Cohort B - HRD/CDK12 PARP - Progressors

EXPERIMENTAL

Combination Product: vudalimab + cabazitaxel or docetaxel

Cohort C - HRD/CDK12 PARP Naïve

EXPERIMENTAL

Combination Product: vudalimab + olaparib

Cohort D - MSI-H, MMRD or TMB-H

EXPERIMENTAL

Biological: vudalimab monotherapy

Cohort E - No Targetable Mutations

EXPERIMENTAL

Combination Product: vudalimab + docetaxel

Interventions

vudalimab + carboplatin + cabazitaxel COMBINATION_PRODUCT

Vudalimab IV, carboplatin IV, cabazitaxel IV

Cohort A - AVPCa

vudalimab + olaparib COMBINATION_PRODUCT

Vudalimab IV, olaparib oral

Cohort C - HRD/CDK12 PARP Naïve

vudalimab monotherapy BIOLOGICAL

Vudalimab IV

Cohort D - MSI-H, MMRD or TMB-H

vudalimab + docetaxel COMBINATION_PRODUCT

Vudalimab IV, docetaxel IV

Cohort E - No Targetable Mutations

vudalimab + cabazitaxel or docetaxel COMBINATION_PRODUCT

Vudalimab IV, cabazitaxel or docetaxel IV

Cohort B - HRD/CDK12 PARP - Progressors

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent
• Adult (age ≥ 18 years)
• Histologically confirmed diagnosis of carcinoma of the prostate
• Documented progressive mCRPC based on at least one of the following criteria:
• PSA progression, defined as at least 2 rises in PSA with a minimum of a 1-week interval
• Soft-tissue progression per RECIST 1.1
• Progression of bone disease (evaluable disease) or 2 or more new bone lesions by bone scan
• Prostate cancer must have progressed following treatment including at least 1 androgen receptor signaling inhibitor (ARSI) agent
• Subjects who did not have a surgical orchiectomy must be on androgen suppression treatment (eg, luteinizing hormone-releasing hormone agonist) with castrate level of testosterone (≤ 50 ng/dL) and be willing to continue the treatment throughout the study
• Prior targeted or whole exome sequencing panel performed by CLIA-certified laboratory documenting:
• Cohort A (AVPCa) - Aggressive variant prostate cancer
• Cohort B or C (HRD) - Homologous recombination deficient (HRD) tumor
• Cohort D (MSI-H/MMRD) - Microsatellite instability-high (MSI-H) or mismatch repair deficient (MMRD) tumors (MSI-H/MMRD) or TMB-H (≥ 10 mut/Mb)
• Cohort E (No Targetable Mutations)
• NOTE: Cohorts B, C, and D are no longer open for enrollment

You may not qualify if:

• Currently receiving anticancer therapies other than androgen deprivation therapy
• Prior treatment with docetaxel (Cohort E only)
• Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
• Disease progression on prior treatment with cabazitaxel plus carboplatin (applicable to subjects eligible for Cohort A) or cabazitaxel alone (applicable to subjects eligible for Cohort E)
• Prior treatment with any cytotoxic T-lymphocyte-associated protein (CTLA4), PD1, PDL1, or programmed cell death ligand 2 (PDL2) directed immunotherapy, except subjects in Cohort D, who will have had prior FDA-approved checkpoint inhibitor therapy
• Failure to recover from any toxicity related to previous anticancer treatment to ≤ Grade 2
• Have known active central nervous system metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, ie, are without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), are clinically stable, and are without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
• Platelet count \< 100 × 109/L
• Hemoglobin level ≤ 9.0 g/dL
• Absolute neutrophil count ≤ 1.7 × 109 for subjects who will receive cabazitaxel; \< 1.0 × 109/L for all others
• Aspartate aminotransferase at screening \> 3 × upper limit of normal (ULN) for subjects without known liver involvement by tumor or \> 5 × ULN for subjects with known liver involvement by tumor
• Alanine aminotransferase at screening \> 3 × ULN for subjects without known liver involvement by tumor or \> 5 × ULN for subjects with known liver involvement by tumor
• Bilirubin ≥ 1.5 × ULN (unless prior diagnosis and documentation of ongoing hemolysis or Gilbert's syndrome has been made)
• Estimated creatinine clearance \< 50 mL/minute calculated by the Cockcroft Gault or Modification of Diet in Renal Disease formulas
• Active known or suspected autoimmune disease (except vitiligo; type 1 diabetes mellitus or residual hypothyroidism due to an autoimmune condition that is treatable with hormone replacement therapy only; psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed without systemic therapy; or arthritis that is managed without systemic therapy beyond oral acetaminophen and nonsteroidal anti-inflammatory drugs)

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (26)

Alaska Oncology and Hematology

Anchorage, Alaska, 99508, United States

Location

Palo Verde Hematology Oncology

Glendale, Arizona, 85304, United States

Location

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

VA Greater Los Angeles

Los Angeles, California, 90064, United States

Location

University of California, San Diego

San Diego, California, 92093, United States

Location

Rocky Mountain Cancer Centers

Lone Tree, Colorado, 80124, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kansas Clinical Research Center

Fairway, Kansas, 66205, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

GU Research Network/Urology Cancer Center

Omaha, Nebraska, 68130, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148, United States

Location

XCancer New Mexico Oncology Hematology Consultants, Ltd.

Albuquerque, New Mexico, 87109, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Northwest Cancer Specialists

Tigard, Oregon, 97223, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Central South

Weslaco, Texas, 78596, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

University of Washington/Seattle Cancer Care/Alliance

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Carboplatin; cabazitaxel; olaparib; Docetaxel

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Jolene Shorr

  Xencor, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 13, 2021
• Study Start: October 22, 2021
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (26)