A Double-blind, Randomized Phase II Trial of Active Immunotherapy with Globo H-KLH (OPT-822) in Subjects with Metastatic Breast Cancer

Study Status

Open to Enrollment

Study Description

This is a clinical trial for patients with stage 4 or metastatic breast cancer. The purpose of this study is to evaluate the effectiveness of the vaccine OPT-822 given together with low dose cytoxan in delaying progression of cancer.  

OPT-822 is expected to stimulate the immune system to produce antibodies specific for Globo H. Globo H is highly present in breast cancer cells. Low dose cyclophosphamide is given in this study to enhance the immune system response against tumors.

Study participants will be randomly assigned to one of two treatment groups:

  • Group 1: OPT-822/OPT-821 plus cyclophosphamide
  • Group 2: Placebo (looks like OPT-822/OPT-821 but contains no medicine) plus cyclophosphamide

Participants will not know if they are receiving OPT-822/OPT-821 or placebo. All study participants will receive low dose cyclophosphamide.

Cyclophosphamide will be given via infusion at Weeks 1, 5, 9, 13, 17, 25 and 37 or until disease progression. OPT-822/OPT-821 or placebo will be given via subcutaneous injection at Weeks 1, 2, 3, 5, 9, 13, 17, 25 and 37 until disease progression or up to 2 years from entering the study.

After completing all study treatments, participants will have follow-up every 8 weeks for the researchers to check up on patients’ health status for up to 2 years from study entry. 

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Disease Status and/or Stage

Metastatic Breast Cancer

Sponsor

Optimer Biotechnology

Key Eligibility

  • Women age 21 or older
  • Diagnosed with metastatic breast cancer
  • Achieved stable disease, partial response or complete response after at least 1 regimen of chemotherapy
  • Have had no more than 2 events of disease progression (PD) after the development of metastatic breast cancer
  • Detailed eligibility reviewed when you contact the study team

Principal Investigator

Ellen Chuang, MD

Contact

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Erica Bersin
Tel: (646) 962-8232
[email protected]

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