Not recruiting

Study of Adagloxad Simolenin/OBI-821, Capecitabine, and Pembrolizumab for Patients with High-Risk, Early-Stage Triple Negative Breast Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of breast cancer known as Triple Negative Breast Cancer (TNBC). This form of cancer is called "triple negative" because the cancer cells do not have three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and HER2/neu. The study is testing a treatment called Adagloxad Simolenin (also known by its code name OBI-822/OBI-821), which is a vaccine designed to help the immune system fight cancer cells. The purpose of the study is to see if this treatment can improve the time patients remain free from invasive cancer after their initial treatment.

Participants in the study will receive the Adagloxad Simolenin treatment, which is given as an injection under the skin. Some participants may also receive other treatments like Capecitabine, a chemotherapy drug taken by mouth, or Pembrolizumab, a type of immunotherapy given through an intravenous infusion. The study will compare the effects of these treatments to see which is more effective in preventing the return of cancer. Some participants may receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of the treatments being tested.

The study will follow participants over a period of time to monitor their health and any changes in their condition. Researchers will look at how long participants remain free from cancer, their overall survival, and their quality of life during the study. The study aims to provide valuable information on the effectiveness of Adagloxad Simolenin and other treatments in managing Triple Negative Breast Cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.
Consent is required to participate, and a signed document is necessary before any study procedures begin.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline. This includes imaging tests to ensure no evidence of metastatic disease and evaluation of health-related quality of life.
Step 3
Randomization
Participants are randomly assigned to receive either the study treatment or a standard care regimen. This occurs within 16 weeks after surgery and any additional therapy.
Step 4
Treatment phase
The treatment involves the administration of adagloxad simolenin (OBI-822) with an adjuvant (OBI-821).
The treatment is given as a subcutaneous injection and may be combined with other medications like capecitabine (oral use) or pembrolizumab (intravenous infusion), depending on the assigned group.
Step 5
Monitoring and follow-up
Regular monitoring is conducted to assess the treatment's effect on disease-free survival and overall health.
Participants complete questionnaires to evaluate changes in quality of life and report any side effects experienced during the study.
Step 6
Completion of study
The study is expected to conclude by the end of 2025. Participants will have a final assessment to determine the overall impact of the treatment on their condition.

Who can join the trial?

15 criteria

Must be a male or female patient who is at least 18 years old.
Must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG) scale, which measures how well a patient can perform daily activities.
Females must either be unable to have children (due to surgery or menopause) or have a negative pregnancy test if they can have children.
Males and females who can have children must agree to use effective birth control during the study and for at least 4 weeks after the last treatment.
Must have adequate blood, liver, and kidney function, which includes specific levels of blood cells, liver enzymes, and kidney markers.
Must agree to participate by signing a consent form approved by an ethics committee.
Must be able to understand and willing to complete all required study procedures.
Must have confirmed primary localized invasive breast cancer through imaging and tissue examination.
Must have Triple Negative Breast Cancer (TNBC), which means the cancer does not have receptors for estrogen, progesterone, or HER2.
Must have a specific level of Globo H protein in the tumor, determined by a laboratory test.
Must show no signs of cancer spread to the chest, abdomen, or pelvis in imaging tests done within 3 months before starting the study.
Must be considered high-risk but show no evidence of disease after standard treatment, meeting specific criteria related to previous chemotherapy and surgery.
Must have completed at least 4 cycles of a standard chemotherapy regimen, which includes specific drugs, either before or after surgery.
Must be randomized into the study within 16 weeks after surgery and any radiation therapy, depending on the type of chemotherapy received.
All side effects from previous treatments must be resolved to a mild level, except for hair loss and mild nerve damage, which are acceptable.

Who cannot join the trial?

5 criteria

Patients who have a different type of breast cancer other than Triple Negative Breast Cancer cannot participate. Triple Negative Breast Cancer is a type of breast cancer that does not have three common receptors known to fuel most breast cancer growth.
Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
Patients who are not part of the specified clinical trial group cannot participate. Clinical trial groups are specific categories or classifications used in the study.
Patients who are not female or male subjects as specified by the study cannot participate.
Patients who are considered part of a vulnerable population, as defined by the study, cannot participate. Vulnerable populations may include groups like children, pregnant women, or others who may need special protection.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Verified
Cracow, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Verified
Cracow, Poland
Uniwersyteckie Centrum Kliniczne
Verified
Gdansk, Poland

Trial locations

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Investigated drugs

Adagloxad Simolenin (OBI-822)
is a vaccine designed to help the immune system recognize and attack cancer cells. It targets a specific molecule called Globo H, which is found on the surface of some cancer cells. This vaccine is being studied to see if it can help prevent the return of cancer in patients with high-risk, early-stage triple-negative breast cancer.
OBI-821
is used in combination with Adagloxad Simolenin (OBI-822) to enhance the immune response. It acts as an adjuvant, which means it helps boost the effectiveness of the vaccine, making the immune system more likely to attack the cancer cells.

What is already known about the treatment

Adagloxad Simolenin (OBI-822)/OBI-821 – This medication is administered as an injection and is currently being studied in clinical trials for its potential use in treating high-risk, early-stage Globo H-positive triple negative breast cancer. It is in the experimental phase and not yet widely available in medical practice. The main therapeutic indication is to improve invasive disease-free survival in patients with this specific type of breast cancer. At the molecular level, it works by targeting the Globo H antigen, which is present on the surface of certain cancer cells, helping the immune system to recognize and attack these cells. It is classified as a cancer vaccine, aiming to stimulate the body's immune response against cancer cells.

Investigated diseases

Triple Negative Breast Cancer – This is a type of breast cancer that does not have any of the three common receptors known to fuel most breast cancer growth: estrogen, progesterone, and the HER-2/neu gene. It is considered more aggressive and difficult to treat than other types of breast cancer. The cancer cells in triple negative breast cancer do not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. It tends to grow and spread more quickly than other types of breast cancer. This type of cancer is more likely to affect younger women and those with a BRCA1 gene mutation. It is often diagnosed at a higher grade and stage than other breast cancers.