Study on the Safety and Effectiveness of ALX148 with Chemotherapy and Immunotherapy for Recurrent Platinum-resistant Ovarian Cancer

Sponsor: Alexander B Olawaiye, MD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05467670

Provider View

This clinical trial is testing a new treatment combination for women with ovarian cancer that has returned and is resistant to platinum-based chemotherapy. The study involves using ALX148, a drug that targets a protein on cancer cells, along with standard chemotherapy and immunotherapy.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for women with ovarian cancer that has come back and does not respond to platinum-based chemotherapy. The treatment combines ALX148, which targets a protein called CD47 on cancer cells, with standard chemotherapy (liposomal doxorubicin) and the immunotherapy drug pembrolizumab. The goal is to see if this combination is safe and can help control the cancer.

Description

Participants in this study will receive a combination of three treatments: a chemotherapy drug called Pegylated Liposomal Doxorubicin (PLD), the immunotherapy drug pembrolizumab, and a new drug called ALX148. These treatments will be given through an IV every 21 days. The study will continue until the cancer progresses, the patient experiences severe side effects, or the study ends. If a patient responds completely to the treatment, they may continue with pembrolizumab and ALX148 for up to 12 months as maintenance therapy. Patients will be monitored closely, and follow-up visits will occur about a month after the last treatment.

Eligibility Criteria

Inclusion Criteria

  • Women with recurrent ovarian cancer that is resistant to platinum-based chemotherapy.
  • Cancer types include high-grade serous, endometrioid, clear cell, and other specified types.
  • Up to 5 previous treatments allowed, with 0-3 in the platinum-resistant setting.
  • Must have measurable cancer based on specific criteria.
  • Must be 18 years or older and in good overall health.
  • Must have normal organ and bone marrow function.
  • Must be able to understand and sign a consent form.
  • Must not be pregnant and agree to use effective birth control during the study.
  • Must provide a sample of tumor tissue for analysis.

Exclusion Criteria

  • Patients with certain types of cancer like sarcoma or low-grade carcinoma.
  • Patients whose cancer did not respond to initial platinum-based therapy.
  • Recent treatment with other cancer therapies or radiation.
  • Active brain metastases or certain untreated brain conditions.
  • Previous treatment with specific immunotherapy drugs.
  • Active autoimmune diseases or conditions requiring immunosuppressive therapy.
  • Pregnant or breastfeeding women.
  • History of severe heart disease or other serious medical conditions.
  • Active infections like hepatitis or HIV, unless well-controlled.
  • Recent vaccination with live vaccines.
  • Known severe allergies to study drugs.
  • Other medical conditions that could interfere with the study.

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