What side effects are associated with this type of intervention?

Common side effects of immune modulation therapies, such as those involving PD-1 and CTLA-4 inhibitors, include skin reactions (e.g., rash and pruritus), endocrine disorders (e.g., thyroid dysfunction), gastrointestinal issues (e.g., diarrhea and colitis), and respiratory complications (e.g., pneumonitis). These treatments can also lead to more severe adverse events like hepatitis, nephritis, and myocarditis. The frequency and severity of these side effects can vary, and they may necessitate discontinuation of therapy or the use of immunosuppressive medications.

What prior FDA approvals exist?

The FDA has approved several immune-modulating therapies for cancer treatment, focusing on checkpoint inhibitors that target PD-1, PD-L1, and CTLA-4 pathways. Pembrolizumab (Keytruda) and nivolumab (Opdivo) are PD-1 inhibitors approved for various cancers, including melanoma and non-small cell lung cancer. Ipilimumab (Yervoy), a CTLA-4 inhibitor, is approved for melanoma. Combination therapies, such as nivolumab with ipilimumab, have also been approved for enhanced efficacy in treating advanced melanoma. These approvals highlight the FDA's recognition of immune modulation as a critical approach in cancer therapy.

What other types of research exist?

Promising novel alternatives to AGEN1777 for cancer patients include: <ol> <li>Nivolumab plus Ipilimumab: Combination immunotherapy has shown improved treatment-free survival in advanced melanoma and other cancers.</li> <li></li> </ol> Pembrolizumab: Effective in various cancers, including non-small cell lung cancer and melanoma, especially in PD-L1 positive patients. 3. Atezolizumab: Demonstrated efficacy in urothelial carcinoma and non-small cell lung cancer. 4. Enfortumab Vedotin: A novel antibody-drug conjugate showing promise in urothelial carcinoma. 5. Nivolumab-relatlimab: A combination therapy showing potential in metastatic melanoma. 6. Venetoclax plus Obinutuzumab: Effective in chronic lymphocytic leukemia, particularly in achieving undetectable minimal residual disease.

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Monoclonal Antibodies

AGEN1777 + PD-1 Inhibitor for Cancer

Phase 1

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

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 acceptable standard therapy available or progressed on or after standard therapies.

Life expectancy of at least 3 months and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Must not have

Active infection requiring treatment.

Clinically significant cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AGEN1777, both by itself and with another drug that helps the immune system fight cancer. It targets patients with advanced cancers that have spread to other parts of the body. The goal is to see if this treatment can help the immune system better recognize and destroy cancer cells.

Who is the study for?

This trial is for adults with advanced solid tumors that have no standard treatment options left or didn't respond to previous treatments. Participants must have a life expectancy of at least 3 months, be relatively active and well (ECOG status 0 or 1), and their disease must be measurable on scans.

What is being tested?

The study tests AGEN1777 alone and combined with a PD-1 inhibitor in patients with advanced cancer. It aims to assess the safety, how the body processes it (pharmacokinetics), and its effects on the body's response to disease (pharmacodynamics).

What are the potential side effects?

Potential side effects may include typical reactions seen with immune therapies such as fatigue, skin reactions, inflammation in organs like lungs or intestines, flu-like symptoms, changes in blood pressure or heart rhythm.

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 have failed or are not suitable.

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I am expected to live at least 3 more 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 am currently being treated for an infection.

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I haven't had major heart issues or strokes in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Monotherapy with AGEN1777Experimental Treatment1 Intervention

3+3 Dose escalation of AGEN1777 will be administered by Intravenous (IV) infusion every 3 weeks (each cycle is 21 days \[3 weeks\]).

Group II: AGEN1777 in combination with a PD-1 inhibitorExperimental Treatment2 Interventions

3+3 Dose escalation of AGEN1777 in combination with a PD-1 inhibitor will be administered by IV infusion with specified dose on specified days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

a PD-1 inhibitor

2021

Completed Phase 1

~30

AGEN1777

2021

Completed Phase 1

~30

0 / 4Eligibility 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

Immune modulation therapies, such as PD-1 and PD-L1 inhibitors, enhance the body's immune response against cancer by blocking proteins that inhibit T-cells from attacking cancer cells. This mechanism boosts the immune system's ability to target and destroy cancer cells, offering cancer patients a potentially more effective and durable treatment option compared to traditional therapies.

Basic overview of current immunotherapy approaches in urologic malignancy.