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Metastatic Castration-Resistant Prostate CancerPhase 2NCT05005728

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

A Phase 2 study testing vudalimab + carboplatin + cabazitaxel, vudalimab + olaparib and vudalimab monotherapy in people with Metastatic Castration-Resistant Prostate Cancer, run by Xencor, Inc. at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
vudalimab + carboplatin + cabazitaxel, vudalimab + olaparib and vudalimab monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
26 sitesUnited States
Study dates
22 Oct 2021to 10 Jun 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Evaluable disease according to PCWG3 criteria
  • Adequate archival metastatic tumor tissue or agree to undergo a biopsy of at least 1 metastatic site (fresh biopsy of primary prostate is only allowed if there is clear local disease and no other measurable disease site or biopsiable bone lesion)
  • ECOG performance status of 0 or 1
  • Able and willing to complete the study according to the study schedule

Who cannot join

  • 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
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  • 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)
  • Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug (except inhaled or topical corticosteroids or brief courses of corticosteroids given for prophylaxis of contrast dye allergic response). Subjects who are currently taking prednisone from a previous prostate cancer therapy will be permitted to enroll in the study.
  • Receipt of an organ allograft
  • Known history of left ventricular ejection fraction ≤ 40%
  • History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease other than their primary malignancy that, in the opinion of the Investigator, would pose a risk to patient safety or interfere with study evaluations, procedures, or completion
  • Evidence of any serious bacterial, viral, parasitic, or systemic fungal infections within the 30 days prior to the first dose of study drug
  • Receipt of a live-virus vaccine within 30 days prior to the first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted)
  • Known human immunodeficiency virus (HIV) positive subject with CD4+ T-cell (CD4+) counts < 350 cells/μL, or an HIV viral load greater than 400 copies/mL, or a history of an AIDS (acquired immunodeficiency syndrome)-defining opportunistic infection within the past 12 months, or who has not been on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. (Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load.) (HIV positive subjects who do not meet any of these exclusion criteria are eligible)
  • Positive test for hepatitis C RNA (a subject who is hepatitis C virus [HCV] antibody positive but HCV RNA negative due to documented, curative prior antiviral treatment or natural resolution is eligible)
  • Positive test for HBsAg or HBcAb (a subject whose HBsAg is negative and HBcAb is positive may be enrolled if a HBV DNA test is negative and the subject is retested for HBsAg and HBV DNA every 2 months)

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

United States26 sites

  • XCancer New Mexico Oncology Hematology Consultants, Ltd.

    Albuquerque, New Mexico, 87109

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

  • City of Hope

    Duarte, California, 91010

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Palo Verde Hematology Oncology

    Glendale, Arizona, 85304

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Rocky Mountain Cancer Centers

    Lone Tree, Colorado, 80124

  • VA Greater Los Angeles

    Los Angeles, California, 90064

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

  • Columbia University

    New York, New York, 10032

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • GU Research Network/Urology Cancer Center

    Omaha, Nebraska, 68130

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California, San Diego

    San Diego, California, 92093

  • University of Washington/Seattle Cancer Care/Alliance

    Seattle, Washington, 98109

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Northwest Cancer Specialists

    Tigard, Oregon, 97223

  • Texas Oncology-Central South

    Weslaco, Texas, 78596

Other trials in United States

About this study

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

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.

Read the 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
Being tested
vudalimab + carboplatin + cabazitaxel, vudalimab + olaparib, vudalimab monotherapy, vudalimab + docetaxel, vudalimab + cabazitaxel or docetaxel
Keywords
Prostate cancer, Metastatic castration resistant, Aggressive variant, Anaplastic, Neuroendocrine, Homologous recombination deficiency, MSI-H, CDK12, XmAb20717, Vudalimab
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • vudalimab + carboplatin + cabazitaxelCombination product

    Vudalimab IV, carboplatin IV, cabazitaxel IV

  • vudalimab + olaparibCombination product

    Vudalimab IV, olaparib oral

  • vudalimab monotherapyBiological

    Vudalimab IV

  • vudalimab + docetaxelCombination product

    Vudalimab IV, docetaxel IV

  • vudalimab + cabazitaxel or docetaxelCombination product

    Vudalimab IV, cabazitaxel or docetaxel IV

Study groups in NCT05005728
Study groupRoleWhat they receive
Cohort A - AVPCaExperimentalNot described
Receives: Combination Product: vudalimab + carboplatin + cabazitaxel
Cohort B - HRD/CDK12 PARP - ProgressorsExperimentalNot described
Receives: Combination Product: vudalimab + cabazitaxel or docetaxel
Cohort C - HRD/CDK12 PARP NaïveExperimentalNot described
Receives: Combination Product: vudalimab + olaparib
Cohort D - MSI-H, MMRD or TMB-HExperimentalNot described
Receives: Biological: vudalimab monotherapy
Cohort E - No Targetable MutationsExperimentalNot described
Receives: Combination Product: vudalimab + docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 8 weeks

Secondary outcomes (5)

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

    Measured: 8 weeks

  2. Prostate-specific antigen (PSA) response

    Measured: 8 weeks

  3. Bone scans based on PCWG3 criteria

    Measured: 8 weeks

  4. Radiographic progression-free survival (PCWG3)

    Measured: 8 weeks

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2021
  2. Study start22 Oct 2021
  3. Primary completion10 Jun 2025
  4. Study completion10 Jun 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05005728
Sponsor's protocol ID
XmAb20717-04
Status last verified
May 2026
First submitted
5 Aug 2021
Last updated
5 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vudalimab + carboplatin + cabazitaxel, vudalimab + olaparib and vudalimab monotherapy in people with Metastatic Castration-Resistant Prostate Cancer, run by Xencor, Inc. at 26 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-emergent adverse events (safety and tolerability of vudalimab) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05005728.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

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