What side effects are associated with this type of intervention?

Common side effects of breast cancer treatments that involve immune response modulation and targeted therapies, such as monoclonal antibodies and therapeutic vaccines, include infusion-related reactions (chills, fever, nausea), fatigue, headache, and gastrointestinal issues. Serious adverse events may include cardiac dysfunction, infections, and immune-related side effects like rash, pruritus, and pneumonitis.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of breast cancer. One notable example is pembrolizumab (Keytruda), an immune checkpoint inhibitor that targets the PD-1/PD-L1 pathway, enhancing the body's immune response against cancer cells. Another example is atezolizumab (Tecentriq), which also targets the PD-L1 protein and is used in combination with chemotherapy for triple-negative breast cancer. While these treatments are not vaccines, they share the mechanism of enhancing the immune system's ability to fight cancer, similar to the investigational therapeutic vaccine Adagloxad Simolenin (OBI-822) and OBI-821, which targets the Globo-H antigen to stimulate an immune response.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Trastuzumab Deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2-positive breast cancer. 2) Sacituzumab Govitecan (Trodelvy), an antibody-drug conjugate targeting Trop-2 in triple-negative breast cancer. 3) Pembrolizumab (Keytruda), an immune checkpoint inhibitor for PD-L1 positive breast cancer. 4) Alpelisib (Piqray), a PI3K inhibitor for HR-positive, HER2-negative breast cancer with PIK3CA mutations.

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Cancer Vaccine

Adagloxad Simolenin + OBI-821 for Triple Negative Breast Cancer

Q: What is the mechanism of action of this treatment?

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapy, such as tamoxifen, blocks hormones like estrogen that fuel certain breast cancers. Chemotherapy uses drugs to kill rapidly dividing cancer cells. Targeted therapies, like trastuzumab, specifically target cancer cell proteins such as HER2 to inhibit tumor growth. Immunotherapy, including therapeutic vaccines like Adagloxad Simolenin (OBI-822) and OBI-821, targets specific antigens like Globo-H to stimulate the immune system to attack cancer cells. These treatments are crucial as they offer personalized approaches to effectively manage and treat breast cancer, improving patient outcomes.

Phase 3

Recruiting

Research Sponsored by OBI Pharma, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically documented TNBC (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growth factor 2 negative [HER2-]) defined as ER-negative and PR-negative (≤5% positive cells stain by IHC for both ER and PR), and negative HER2/neu- status, confirmed on tumor sample.

Single-probe average HER2 gene copy number of <6 signals/nucleus

Must not have

Definitive clinical or radiologic evidence of metastatic disease

Oral/parenteral corticosteroid treatment within 2 weeks prior to randomization or anytime during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new treatment that combines two substances to help the immune system fight a specific type of high-risk breast cancer. It focuses on patients whose cancer does not respond well to usual treatments.

Who is the study for?

This trial is for high-risk, early-stage breast cancer patients with Globo H Positive Triple Negative Breast Cancer (TNBC). Participants must have completed standard chemotherapy, have no metastatic disease or other cancers in the last 5 years, and not be on immunosuppressive therapy. They should also agree to use effective contraception.

What is being tested?

The GLORIA study tests adagloxad simolenin (OBI-822)/OBI-821 as an additional treatment after surgery for TNBC. It's compared against standard care treatments to see if it improves outcomes. Patients are randomly assigned to either the new drug combo or standard care.

What are the potential side effects?

Potential side effects of adagloxad simolenin/OBI-821 may include typical immune-related reactions such as inflammation in different body parts, allergic responses, fatigue, and possibly increased susceptibility to infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is triple-negative, not responding to hormones or HER2 treatments.

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My cancer's HER2 gene test shows less than 6 signals per cell.

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My breast cancer is confirmed by imaging and biopsy.

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My breast cancer is triple-negative.

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My side effects from previous treatments are mild or gone.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My scans show no signs of cancer spread in my chest, abdomen, or pelvis.

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I have completed chemotherapy with drugs like Taxol or Adriamycin.

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My breast cancer diagnosis was confirmed with imaging and tissue tests.

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My cancer's HER2 to chromosome 17 ratio is less than 2.

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My cancer has a Globo H score of 15 or more.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to other parts of my body.

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I have not taken any corticosteroids by mouth or injection in the last 2 weeks.

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Both of my breast cancers are confirmed as triple-negative.

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I have received immune-based therapy after surgery.

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I am currently receiving approved cancer treatment or immunotherapy.

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I have not had any other cancers in the last 5 years.

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I am on medication for an autoimmune disease.

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I have previously received a vaccine for cancer treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

Incidence and severity of adverse events (AEs) [Time Frame: AEs will be noted as it occurs, with a timeframe from beginning of randomization to 4 weeks after last dose of study treatment.]

Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Breast cancer-free interval (BCFI).

Measuring the impact of adagloxad simolenin (OBI-822)/OBI-821 treatment in the study population on Distant disease-free survival (DDFS).

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Adagloxad simolenin + OBI-821 in conjunction with SOCExperimental Treatment3 Interventions

Participants will be administered adagloxad simolenin combined with OBI-821 for up to a total of 21 subcutaneous injections over a period of 100 weeks. Patient will also receive standard of care (SOC) treatment.

Group II: Standard of Care treatmentActive Control2 Interventions

Study visit intervals will be identical to those in Arm 1. Patient will receive standard of care (SOC) treatment.

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include hormone therapy, chemotherapy, targeted therapy, and immunotherapy. Hormone therapy, such as tamoxifen, blocks hormones like estrogen that fuel certain breast cancers. Chemotherapy uses drugs to kill rapidly dividing cancer cells. Targeted therapies, like trastuzumab, specifically target cancer cell proteins such as HER2 to inhibit tumor growth. Immunotherapy, including therapeutic vaccines like Adagloxad Simolenin (OBI-822) and OBI-821, targets specific antigens like Globo-H to stimulate the immune system to attack cancer cells. These treatments are crucial as they offer personalized approaches to effectively manage and treat breast cancer, improving patient outcomes.

Future options with trastuzumab for primary systemic and adjuvant therapy.