Study on XmAb®20717 (Vudalimab) Alone or with Chemotherapy or Targeted Therapy for Metastatic Castration-Resistant Prostate Cancer

Sponsor: Xencor, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05005728

Provider View

This Phase 2 clinical trial is exploring the safety and effectiveness of the drug vudalimab (XmAb20717) alone or combined with standard cancer treatments in patients with metastatic castration-resistant prostate cancer (mCRPC) that has worsened despite previous treatments.

Patient Parameters

Program Overview

The study aims to test the safety and effectiveness of vudalimab (XmAb20717) either by itself or with other cancer treatments in patients with metastatic castration-resistant prostate cancer (mCRPC) that has progressed after previous therapies. Participants will be divided into different groups based on specific characteristics of their cancer.

Description

This Phase 2 study is open-label, meaning both the researchers and participants know what treatment is being given. It involves multiple doses and has several groups based on the type of prostate cancer:

  • Cohort A: Patients with aggressive variant prostate cancer (AVPCa).
  • Cohort B: Patients with specific genetic changes in their tumors that have worsened after certain treatments (Closed to Enrollment).
  • Cohort C: Patients with specific genetic changes who have not yet received certain treatments (Closed to Enrollment).
  • Cohort D: Patients with tumors that have high levels of genetic instability or other specific characteristics (Closed to Enrollment).
  • Cohort E: Patients without targetable mutations.

The study will assess how well the treatment works and its safety in these different groups.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide written consent to participate.
  • Must be 18 years or older.
  • Must have a confirmed diagnosis of prostate cancer.
  • Must have evidence of prostate cancer that has spread and worsened despite previous treatments, shown by:
    • Rising PSA levels.
    • New or growing tumors on scans.
    • New bone lesions.
  • Must be on hormone therapy if not surgically castrated, with low testosterone levels, and willing to continue this treatment.
  • Must have had genetic testing showing specific cancer characteristics for certain groups.
  • Must have measurable disease according to specific criteria.
  • Must provide a tumor sample or agree to a biopsy.
  • Must have a good performance status, meaning able to carry out daily activities with minimal restrictions.
  • Must be willing to follow the study schedule and procedures.

Exclusion Criteria

  • Currently receiving cancer treatments other than hormone therapy.
  • Previous treatment with certain chemotherapy drugs (for specific groups).
  • Recent treatment with other cancer therapies within two weeks of starting the study drug.
  • Disease progression on certain previous treatments.
  • Previous treatment with specific types of immunotherapy, except for certain groups.
  • Severe side effects from previous immunotherapy.
  • Not fully recovered from side effects of previous cancer treatments.
  • Active brain metastases or cancer in the brain lining.
  • Low blood cell counts or liver function outside specified limits.
  • Active autoimmune diseases or conditions requiring immune-suppressing medications.
  • Recent organ transplant.
  • Serious infections or recent live-virus vaccinations.
  • Certain viral infections like HIV or hepatitis unless well-controlled.
  • Any other serious health conditions that could interfere with the study.

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