Study on Vudalimab (XmAb20717) for Patients with Advanced Gynecologic and Genitourinary Cancers

Sponsor: Xencor, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05032040

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, vudalimab (XmAb20717), in treating certain advanced gynecologic and genitourinary cancers. The study aims to identify which types of tumors respond best to this treatment.

Patient Parameters

Program Overview

This study is designed to evaluate how well the drug vudalimab works and how safe it is for patients with specific advanced cancers of the reproductive and urinary systems. The trial will be conducted in two stages across multiple centers, with patients grouped based on their type of cancer. The goal is to find out which cancers respond best to vudalimab and to gather more information for future research.

Description

The study involves two stages and includes patients with different types of advanced cancers:

  • Stage 1: Patients will be divided into five groups based on their cancer type, with 10 patients in each group. The groups include:

    • Ovarian cancer that is resistant to platinum-based chemotherapy
    • Clear cell ovarian, endometrial, or peritoneal cancer that has returned or not responded to chemotherapy
    • Endometrial cancer that has not responded to immune checkpoint inhibitors
    • Cervical cancer that has returned or spread after standard treatments
    • Prostate cancer that has spread and is resistant to hormone therapy

    The main goal in Stage 1 is to see if at least 20% of patients in each group show a positive response to the treatment after 12 weeks. If this happens, the group will expand to include more patients in Stage 2.

  • Stage 2: Up to 20 more patients with prostate cancer will be added, regardless of whether their cancer can be measured. The main goal here is to see if the treatment reduces prostate-specific antigen (PSA) levels by 50%.

The study will help determine which types of cancer respond best to vudalimab and provide insights for further research.

Eligibility Criteria

Inclusion Criteria

  • Must be able to provide written consent to participate.
  • Must be 18 years or older.
  • Cancer must have worsened after receiving standard treatments.
  • Must have a confirmed diagnosis of one of the following cancers:
    • Clear cell carcinoma of the ovary, peritoneum, or endometrium that has returned after chemotherapy.
    • High-grade serous carcinoma of the ovary, fallopian tube, or peritoneum that has returned after chemotherapy.
    • Cervical cancer that has returned or spread after standard treatments and immunotherapy.
    • Advanced endometrial cancer that is not suitable for surgery or radiation and has worsened after one prior treatment.
    • Prostate cancer that has spread and is resistant to hormone therapy.
  • Must have measurable disease or specific progression criteria for prostate cancer.
  • Must provide a tumor sample for analysis.
  • Must have a performance status indicating full activity or some restriction in strenuous activities.
  • Women of childbearing potential must use effective birth control during and for 4 weeks after treatment.
  • Men must use effective birth control and agree not to donate sperm during and for 4 weeks after treatment.
  • Must be willing to complete the study as scheduled.

Exclusion Criteria

  • Currently receiving other cancer treatments, except for certain hormone therapies in prostate cancer.
  • Have had more than two prior chemotherapy treatments for certain cancers.
  • Have had more than two prior treatments targeting androgen receptors in prostate cancer.
  • Have received certain immune therapies before.
  • Have had a severe immune-related side effect from previous treatments.
  • Have not recovered from previous treatment side effects.
  • Have active brain metastases or certain blood count levels.
  • Have liver or kidney function outside specified limits.
  • Have active autoimmune diseases requiring treatment.
  • Have received an organ transplant.
  • Have certain bowel conditions or infections.
  • Have received a live vaccine recently.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.
  • Have certain viral infections that are not well-controlled.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.