Study on Neoadjuvant Chemotherapy with or without HCW9218 for Advanced Stage Ovarian Cancer

Sponsor: Haider Mahdi

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05145569

Provider View

This clinical trial is exploring the safety and effectiveness of adding a new drug, HCW9218, to standard chemotherapy for women with advanced stage ovarian cancer. The study aims to see if this combination can better control the cancer before surgery.

Patient Parameters

Program Overview

The study is testing a new treatment approach for women with advanced stage ovarian cancer. It involves using a drug called HCW9218 along with standard chemotherapy to see if it can help shrink tumors before surgery. Researchers believe that HCW9218 may work by blocking a protein that helps cancer spread, potentially making the chemotherapy more effective. The study will also look at how the treatment affects the immune system and whether it can help reverse some of the aging effects on immune cells.

Description

This study is investigating a new treatment for advanced stage ovarian cancer that combines a drug called HCW9218 with standard chemotherapy. HCW9218 is thought to block a protein called TGF-β, which is often found in high levels in ovarian cancer and helps the cancer spread. By blocking this protein, HCW9218 may help the immune system fight the cancer more effectively. The study will also examine how the treatment affects immune cells and whether it can help reverse some of the aging effects on these cells. Participants will receive the treatment before surgery to see if it can shrink the tumors and make them easier to remove.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older with a confirmed diagnosis of advanced stage ovarian cancer.
  • Must be able to give informed consent and agree to follow study requirements.
  • Not pregnant or breastfeeding, and willing to use contraception if of childbearing potential.
  • Have a good performance status and a life expectancy of at least 12 weeks.
  • Diagnosed with advanced stage (III-IV) ovarian, fallopian, or primary peritoneal cancer, and planned to receive neoadjuvant chemotherapy with carboplatin and paclitaxel.
  • Have high-grade serous ovarian cancer and no prior chemotherapy or immune therapy for ovarian cancer.
  • Have measurable disease based on scans, with at least one tumor that can be tracked.
  • Able to provide a tumor sample for analysis.
  • Have adequate organ function based on blood tests.

Exclusion Criteria

  • Pregnant or breastfeeding women, or those planning to become pregnant during the study.
  • Participation in another clinical trial within 4 weeks before starting this study.
  • Previous treatment with TGF-β inhibitors, IL-15, or similar drugs.
  • Prior chemotherapy, radiotherapy, or live vaccines within a specified time before the study.
  • Severe allergies or asthma that are not well controlled.
  • Active infections or medical conditions that require ongoing treatment.
  • History of other cancers unless treated and in remission for at least 2 years.
  • Active brain metastases or autoimmune diseases requiring treatment in the past 2 years.
  • Known infections like HIV, Hepatitis B or C, or tuberculosis unless well controlled.
  • Recent major bleeding events or uncontrolled health conditions like heart failure or high blood pressure.
  • Any condition that might interfere with the study or the patient's ability to participate.

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