Recruiting

Study on the Effectiveness of Botensilimab and Balstilimab for Patients with Various dMMR and pMMR Tumors

InvestigationalNo 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 various types of cancers, including but not limited to, Colorectal Cancer, Esophageal Cancer, Gastric Cancer, Endometrial Cancer, Breast Cancer, Prostate Cancer, and Sarcoma. The study aims to evaluate the effectiveness of a combination of two investigational drugs, Botensilimab and Balstilimab. Botensilimab, also known by its code name AGEN1181, is a type of protein called a monoclonal antibody that targets a specific protein on cancer cells. Balstilimab, or AGEN2034, is another monoclonal antibody that works by blocking a protein that helps cancer cells evade the immune system.

The purpose of this study is to determine how well these drugs work together in treating the cancers mentioned. Participants will receive these medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will observe the response of the tumors to this treatment, particularly looking for a significant reduction in the amount of cancerous tissue remaining after the treatment. This is known as a major pathologic response, where ideally less than 10% of the tumor remains after the treatment.

The study will also assess the safety and feasibility of using these drugs before surgery in patients with these cancers. Participants will be monitored for any side effects and the overall impact of the treatment on their health. The trial will help researchers understand if this combination of drugs can be a beneficial treatment option for patients with these types of cancers.

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, the patient must provide a signed written informed consent.
Eligibility is confirmed based on specific criteria, including age, cancer type, and health status.
Step 2
Initial assessment
An initial assessment is conducted to evaluate the patient's health and eligibility for the trial.
This includes laboratory tests and a review of medical history.
Step 3
Treatment administration
The patient receives two medications: botensilimab and balstilimab.
Both medications are administered as a solution for infusion through an intravenous route.
The frequency and duration of administration are determined by the study protocol.
Step 4
Monitoring and follow-up
Regular monitoring is conducted to assess the patient's response to the treatment.
This includes physical examinations, imaging studies, and laboratory tests.
Step 5
Surgical evaluation
After the treatment phase, a surgical evaluation is performed to assess the tumor response.
The primary goal is to determine the major pathologic response rate, which is defined as having 10% or less viable tumor remaining.
Step 6
End of trial participation
The trial concludes with a final assessment of the patient's health and treatment outcomes.
Long-term follow-up may be conducted to monitor for any recurrence or progression of the disease.

Who can join the trial?

9 criteria

You must sign a written informed consent form, which means you agree to participate in the study after understanding all the details.
If you have a type of cancer called pMMR tumors, you should not need a treatment called neoadjuvant therapy, unless another treatment option is considered standard care.
You must be at least 18 years old.
You should have a type of cancer that has not spread to other parts of the body, known as non-metastatic cancer. This includes specific types like sarcoma, cervical cancer, head and neck cancers, anal cancer, and esophageal cancer.
You must be eligible for a study biopsy, which is a procedure to take a small sample of tissue for testing.
You should have a WHO performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Your blood tests must meet certain criteria, such as having enough white blood cells, platelets, and hemoglobin, and normal liver and kidney function. These tests should be done within 7 days before you start the study.
If you are a woman who can have children, you must use a reliable method of birth control during the study and for 20 weeks after the last dose of the study drug. You must also have a negative pregnancy test within 7 days before starting the study.
If you are a man who is sexually active with a woman who can have children, you must use a reliable method of birth control during the study and for 28 weeks after the last dose of the study drug. You should not donate sperm during this time.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to similar drugs.
Patients who are currently pregnant or breastfeeding.
Patients with active infections that require treatment.
Patients with other serious health conditions that could interfere with the study.
Patients who have received another investigational drug within a certain time frame before the study.
Patients with a history of certain types of cancer that are not part of the study.
Patients who have had a major surgery recently.
Patients with a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.
Patients with a known history of certain immune system disorders.

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Investigated drugs

Botensilimab
is an investigational medication used in this clinical trial. It is being studied for its potential to help the body's immune system recognize and attack cancer cells. In this trial, it is combined with another medication to see if it can improve the treatment outcomes for patients with certain types of tumors.
Balstilimab
is another investigational medication used in the trial. Like botensilimab, it is designed to enhance the immune system's ability to fight cancer. The trial is exploring how well balstilimab works when used together with botensilimab in treating tumors.

What is already known about the treatment

Botensilimab
Botensilimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating various types of tumors, particularly those with deficient mismatch repair (dMMR). It is primarily indicated for use in cancers such as colorectal, esophageal, gastric, and endometrial cancers, among others. Botensilimab works by inhibiting immune checkpoints, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses against cancer.
Balstilimab
Balstilimab is also administered intravenously and is under investigation in clinical trials for its potential to treat tumors with both deficient and proficient mismatch repair (dMMR and pMMR). It is used in combination with botensilimab to enhance the immune response against various cancers, including colorectal and gastric cancers. Balstilimab functions by blocking specific proteins that prevent the immune system from attacking cancer cells, thereby boosting the immune response. It belongs to the pharmacological class of immune checkpoint inhibitors, which are designed to improve the body's ability to fight cancer.

Investigated diseases

Colorectal Cancer
This is a type of cancer that begins in the colon or rectum, parts of the large intestine. It often starts as small, benign clumps of cells called polyps, which can develop into cancer over time. As the disease progresses, it can invade deeper layers of the colon or rectum and spread to nearby lymph nodes or other organs. Symptoms may include changes in bowel habits, blood in the stool, and abdominal discomfort. The progression can vary, with some cases remaining localized while others spread more aggressively.
Esophageal Cancer
This cancer occurs in the esophagus, the long tube that carries food from the throat to the stomach. It typically begins in the cells lining the inside of the esophagus and can grow to invade deeper layers and nearby tissues. As it progresses, it may cause difficulty swallowing, weight loss, and chest pain. The disease can spread to lymph nodes and other organs, complicating its course. The progression rate can differ based on the cancer type and location within the esophagus.
Gastric Cancer
Also known as stomach cancer, this disease starts in the stomach lining and can grow to affect deeper layers and nearby organs. It often begins with subtle symptoms like indigestion and progresses to more severe signs such as weight loss and vomiting. As it advances, it can spread to lymph nodes and distant organs. The progression can be slow or rapid, depending on various factors, including the cancer's type and location.
Duodenal and Small Bowel Cancer
This rare cancer affects the small intestine, particularly the duodenum, which is the first part of the small bowel. It can start in the lining and grow to invade deeper tissues and nearby structures. Symptoms may include abdominal pain, weight loss, and nausea. The disease can spread to lymph nodes and other organs, affecting its progression. The rate of progression can vary significantly among individuals.
Endometrial Cancer
This cancer begins in the lining of the uterus, known as the endometrium. It often presents with abnormal vaginal bleeding, especially after menopause, and can progress to invade the uterine wall and nearby tissues. As it advances, it may spread to lymph nodes and other parts of the body. The progression can be influenced by factors such as hormone levels and the cancer's specific characteristics.
Breast Cancer
This is a common cancer that starts in the breast tissue, often in the ducts or lobules. It can grow to invade surrounding tissues and spread to lymph nodes and other organs. Symptoms may include a lump in the breast, changes in breast shape, and skin dimpling. The progression can vary widely, with some cancers growing slowly and others spreading rapidly.