What side effects are associated with this type of intervention?

Common treatments for ovarian cancer, including immune checkpoint inhibitors like Anti-CTLA-4 and Anti-PD-1 monoclonal antibodies, often result in a range of side effects. These can include fatigue, anemia, and gastrointestinal issues such as diarrhea and nausea. Immune-related adverse events are also notable, with potential skin reactions, pneumonitis, and colitis. Chemotherapy, another common treatment, frequently causes hair loss, neuropathy, and increased risk of infection due to bone marrow suppression. Targeted therapies like Olaparib can lead to fatigue and anemia as well.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of various cancers, including those targeting the CTLA-4 and PD-1/PD-L1 pathways. For ovarian cancer, pembrolizumab (an anti-PD-1 monoclonal antibody) has been approved for use in patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors, which can include ovarian cancer. While there are no specific FDA approvals for anti-CTLA-4 monoclonal antibodies like Botensilimab in ovarian cancer, the combination of anti-CTLA-4 and anti-PD-1 therapies has shown promise in other cancers and is being actively studied in clinical trials for ovarian cancer.

What other types of research exist?

Promising novel alternatives for ovarian cancer treatment in 2024 include: 1) Pembrolizumab (Anti-PD-1 Monoclonal Antibody), which has shown efficacy in various cancers including ovarian cancer. 2) Atezolizumab (Anti-PD-L1 Monoclonal Antibody), which has been studied in combination with other agents for ovarian cancer. 3) Niraparib (PARP Inhibitor), which is effective in patients with BRCA mutations and has shown promise in combination with immunotherapies. 4) Bevacizumab (Anti-VEGF Monoclonal Antibody), which is used in combination with chemotherapy for advanced ovarian cancer.

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Monoclonal Antibodies

Fc-Engineered Anti-CTLA-4 Monoclonal Antibody for Advanced Cancer

Phase 1

Recruiting

Research Sponsored by Agenus Inc.

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumor for which no standard therapy is available or standard therapy has failed.

Measurable disease on imaging based on RECIST 1.1, except for prostate cancer.

Must not have

Active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug, allogeneic tissue/solid organ transplant, active infection requiring systemic treatment, known history of human immunodeficiency virus type 1 or 2 antibodies, known active infection with hepatitis B and/or hepatitis C virus, and clinically significant cardiovascular disease.

History of severe hypersensitivity reaction to a fully human monoclonal antibodies, immune-related adverse event requiring treatment with systemic steroids for > 7 days, interstitial lung disease, uncontrolled asthma, or other specific conditions.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up first study dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two new drugs that help the immune system fight cancer. It targets adults with advanced cancers that haven't responded to other treatments. The drugs work by blocking proteins that usually prevent the immune system from attacking cancer cells.

Who is the study for?

This trial is for adults with certain advanced cancers, like colorectal or ovarian cancer, who have no standard treatment options left or those that failed. They must expect to live at least 3 more months, be relatively active and healthy enough for daily life (ECOG status of 0-1), have proper organ function, not be pregnant, agree to use contraception, and provide a recent tumor tissue sample.

What is being tested?

The study tests botensilimab alone and combined with balstilimab in patients with advanced solid tumors. It's an early-phase trial aiming to find the safest dose levels (MTD) and the recommended doses for future studies (RP2D). The effects on the body are closely monitored through lab tests.

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in different parts of the body, infusion-related reactions which can occur during or after drug administration, fatigue, possible liver issues due to altered enzyme levels, skin rash or itching.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced, and standard treatments haven't worked or aren't available.

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My cancer can be measured on scans, except if it's prostate cancer.

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I am expected to live more than 3 months and can care for myself with minimal assistance.

Exclusion Criteria

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

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I haven't needed systemic treatment for an autoimmune disease, had an organ transplant, or had significant infections or heart disease recently.

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I have had severe allergic reactions to certain medications or have specific lung or immune conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ first study dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~first study dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and first study dose to first observation of documented disease progression (or death within 12 weeks of last tumor assessment) (up to 2 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

DLT Of Botensilimab

Incidence Of Treatment-emergent Adverse Events (TEAEs)

RP2D Of Botensilimab

Secondary study objectives

Anti-drug Antibodies (ADAs)

Area Under The Drug Concentration-time Curve From Time Zero To Infinity [AUC(0-∞)]

Area Under The Drug Concentration-time Curve Within Time Span t1 To t2 At Steady-state (AUC(t1-t2)-ss)

+13 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: 6-Week MonotherapyExperimental Treatment1 Intervention

3+3 Dose escalation: botensilimab, every 6 weeks, starting at dose level 1 mg/kg up to 4 mg/kg, administered IV for up to 2 years.

Group II: 6-Week Combination TherapyExperimental Treatment2 Interventions

3+3 Dose escalation: balstilimab, every 2 weeks, at dose level 3 mg/kg in combination with botensilimab, every 6 weeks, starting at dose level 0.1 mg/kg up to 4 mg/kg, administered IV for up to 2 years. Participants enrolled at sites in the United Kingdom (UK) may have the option for extended treatment. An additional cohort will investigate balstilimab, every 3 weeks, at 450 mg in combination with botensilimab every 6 weeks, at 150 mg, administered IV for up to 2 years.

Group III: 3-Week MonotherapyExperimental Treatment1 Intervention

3+3 Dose escalation: botensilimab, every 3 weeks, starting at dose level 0.1 milligrams/kilogram (mg/kg) up to 4 mg/kg, administered intravenously (IV) for up to 2 years.

0 / 5Eligibility 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

The most common treatments for ovarian cancer include surgery, chemotherapy, and targeted therapies. Recently, immunotherapy agents like Botensilimab (Anti-CTLA-4 Monoclonal Antibody) and Balstilimab (Anti-PD-1 Monoclonal Antibody) have been studied. These agents work by inhibiting immune checkpoints (CTLA-4 and PD-1), which normally act to downregulate immune responses. By blocking these checkpoints, the treatments enhance the immune system's ability to recognize and attack cancer cells. This mechanism is crucial for ovarian cancer patients as it offers a novel approach to potentially improve immune-mediated tumor control and patient outcomes.