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Cancer Vaccine

Adagloxad Simolenin + OBI-821 for Triple Negative Breast Cancer

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 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.

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.

Find a Location

Who is running the clinical trial?

OBI Pharma, IncLead Sponsor
8 Previous Clinical Trials
827 Total Patients Enrolled
Hope Rugo, MDStudy ChairUniversity of California, San Francisco
4 Previous Clinical Trials
264 Total Patients Enrolled
2 Trials studying Breast Cancer
110 Patients Enrolled for Breast Cancer

Media Library

Adagloxad Simolenin (OBI-822) (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT03562637 — Phase 3
Breast Cancer Research Study Groups: Standard of Care treatment, Adagloxad simolenin + OBI-821 in conjunction with SOC
Breast Cancer Clinical Trial 2023: Adagloxad Simolenin (OBI-822) Highlights & Side Effects. Trial Name: NCT03562637 — Phase 3
Adagloxad Simolenin (OBI-822) (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03562637 — Phase 3
~111 spots leftby Dec 2025