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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
Study Summary
This trial will test a new combination drug to treat triple negative breast cancer.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
My breast cancer is triple-negative.
Select...
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.
Select...
I have completed chemotherapy with drugs like Taxol or Adriamycin.
Select...
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.
Select...
My cancer has a Globo H score of 15 or more.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
OBI Pharma, IncLead Sponsor
7 Previous Clinical Trials
746 Total Patients Enrolled
Hope Rugo, MDStudy ChairUniversity of California, San Francisco
4 Previous Clinical Trials
278 Total Patients Enrolled
2 Trials studying Breast Cancer
124 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not able to have children or I have a negative pregnancy test.My breast cancer is triple-negative, not responding to hormones or HER2 treatments.My cancer has spread to other parts of my body.I have not taken any corticosteroids by mouth or injection in the last 2 weeks.My blood, liver, and kidney functions are all within normal ranges.My cancer's HER2 gene test shows less than 6 signals per cell.You are allergic to any of the ingredients in the study drug or have had a severe allergic reaction to fusion proteins.I have had breast cancer return or a new one in either breast within the last 10 years.Both of my breast cancers are confirmed as triple-negative.I have received immune-based therapy after surgery.I am currently receiving approved cancer treatment or immunotherapy.I have not had any other cancers in the last 5 years.You have an active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) before starting the study.My breast cancer is confirmed by imaging and biopsy.My breast cancer is triple-negative.My side effects from previous treatments are mild or gone.I am on medication for an autoimmune disease.I have previously received a vaccine for cancer treatment.My scans show no signs of cancer spread in my chest, abdomen, or pelvis.I am at high risk and have finished my standard treatment.I have completed chemotherapy with drugs like Taxol or Adriamycin.I am willing to use effective birth control.I am fully active or restricted in physically strenuous activity but can do light work.I am HIV positive but my viral load is undetectable due to effective treatment.My breast cancer diagnosis was confirmed with imaging and tissue tests.My cancer's HER2 to chromosome 17 ratio is less than 2.My cancer has a Globo H score of 15 or more.Your IHC test result is 0 or 1+.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care treatment
- Group 2: Adagloxad simolenin + OBI-821 in conjunction with SOC
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there many research facilities trialing this in Canada?
"There are a total of 15 sites where this clinical trial is being conducted. Some notable locations are Nebraska Hematology Oncology PC in Lincoln, University of Chicago Medical in Chicago, and UCSF Helen Diller Family Comprehensive Cancer Centre in San Francisco."
Answered by AI
Has the FDA cleared adagloxad simolenin for use with OBI-821?
"Adagloxad simolenin's safety has been supported by multiple rounds of clinical data, resulting in a score of 3."
Answered by AI
Are enrollments still open for volunteers of this research?
"Yes, as the clinicaltrials.gov website attests, this study is still looking for volunteers. This research project was originally posted on December 5th, 2018 and was updated as recently as July 5th, 2022."
Answered by AI
To your knowledge, how many times has this combination been tested before?
"There is currently one active study involving adagloxad simolenin combined with OBI-821, which is in Phase 3. The majority of the study's locations are in Kyiv and New jersey, but there are a total of 101 sites running clinical trials for this combination."
Answered by AI
Who else is applying?
What state do they live in?
Michigan
Virginia
California
How old are they?
65+
What site did they apply to?
Long Beach Memorial Medical Center
University of Chicago Medical
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Typically responds via
Phone Call
Average response time
- < 1 Day
Most responsive sites:
- Long Beach Memorial Medical Center: < 24 hours
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