Study on Adagloxad Simolenin (OBI-822)/OBI-821 for Treating Globo H Positive Triple-Negative Breast Cancer

Inclusion Criteria

• Confirmed diagnosis of localized invasive breast cancer through imaging and lab tests.
• Diagnosed with triple-negative breast cancer (TNBC), meaning the cancer does not have estrogen, progesterone, or HER2 receptors.
• Globo H positive, as determined by specific lab tests on tumor samples.
• No signs of cancer spread to other parts of the body, based on recent imaging tests.
• Considered high-risk but with no evidence of disease after completing standard treatment, meeting specific criteria related to surgery and chemotherapy.
• Completed at least 4 cycles of standard chemotherapy, unless side effects prevented it.
• Randomization into the study must occur within 12 weeks after finishing standard treatment and within 46 weeks from surgery.
• Resolved treatment-related side effects to a mild level, except for hair loss and mild nerve damage.
• Good overall health with an ECOG performance status of 0 or 1.
• Women must not be pregnant and must use effective birth control during the study and for 4 weeks after.
• Men and women of childbearing potential must agree to use effective contraception during the study and for 4 weeks after.
• Adequate blood, liver, and kidney function as determined by specific lab tests.
• Willingness to sign informed consent and comply with study procedures.

Exclusion Criteria

• History of breast cancer in the same or opposite breast within the last 10 years.
• Evidence of cancer spread to other parts of the body.
• Having cancer in both breasts unless both are TNBC.
• Received any post-surgery immunotherapy or other cancer vaccines.
• Currently receiving other cancer treatments or immunotherapy, except for certain allowed medications.
• History of other cancers within the last 5 years, except for certain skin or thyroid cancers.
• Active autoimmune diseases requiring systemic treatment, except for skin conditions treatable with topical steroids.
• Use of oral or injected steroids above a certain dose within 2 weeks before the study.
• Any uncontrolled illness that could interfere with the study, such as infections or heart problems.
• Allergies to ingredients in the study drugs.
• Previous use of certain cancer vaccines.
• HIV positive unless on effective treatment with undetectable viral load.
• Active hepatitis B or C infection, unless treated and under control.
• Any condition that poses a risk for participating in the study.
• Pregnant or breastfeeding women.
• Participation in another breast cancer trial within 4 weeks before the study.