What side effects are associated with this type of intervention?

Common treatments for pancreatic cancer, such as gemcitabine and nab-paclitaxel, are associated with side effects including fatigue, neuropathy, neutropenia, nausea, and diarrhea. Anti-PD-1 antibodies like Balstilimab can cause immune-related adverse effects such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Novel agents like AGEN1423 may have unique side effects that are still being studied, but they could potentially include similar immune-related toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for pancreatic cancer, primarily focusing on chemotherapy agents such as gemcitabine and nab-paclitaxel. Immune checkpoint inhibitors like pembrolizumab (an anti-PD-1 antibody) have been approved for cancers with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR), which can include pancreatic cancer. However, the combination of novel agents like AGEN1423 and Balstilimab represents a new approach under investigation, aiming to enhance the immune response against pancreatic cancer.

What other types of research exist?

Promising novel alternatives for pancreatic cancer treatment in 2024 include: 1) Pembrolizumab (anti-PD-1 antibody) which has shown efficacy in various cancers and is being explored in combination with other agents for pancreatic cancer. 2) Nivolumab (another anti-PD-1 antibody) often used in combination with Ipilimumab (anti-CTLA-4 antibody) for enhanced immune response. 3) Durvalumab (anti-PD-L1 antibody) combined with Tremelimumab (anti-CTLA-4 antibody) which has shown potential in other solid tumors. 4) Lutetium-177-PSMA-617, a radioligand therapy, which is being investigated for its targeted approach in various cancers.

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AGEN1423 + Balstilimab With/Without Chemo for Pancreatic Cancer

Phase 2

Recruiting

Research Sponsored by Bruno Bockorny

Eligibility Criteria Checklist

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

Must have

Complete resolution of toxic effect(s) of the most recent prior chemotherapy to Grade 1 or less (except alopecia and peripheral neuropathy)

ECOG status ≤1

Must not have

Received a live vaccine within 30 days of the planned start of study therapy

Diagnosis of immunodeficiency or receiving systemic steroid therapy within 7 days prior to the first dose of trial treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 8 weeks until eot, for up to 2 years.

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing new drugs AGEN1423 and Balstilimab, alone or with chemotherapy, for advanced pancreatic cancer patients who didn't respond to previous treatments. The treatment aims to boost the immune system to fight cancer.

Who is the study for?

This trial is for adults with advanced pancreatic ductal adenocarcinoma that's worsened after treatment. They must understand the study, sign consent, have good organ function, use contraception, and not be eligible for curative therapy. Exclusions include other active cancers or treatments, certain medical conditions like heart disease or lung issues, recent vaccines, pregnancy/breastfeeding intentions during the trial period.

What is being tested?

The study tests AGEN1423 and Balstilimab combined with or without chemotherapy drugs gemcitabine and nab-paclitaxel in treating advanced pancreatic cancer. Participants will receive this treatment over two years and then be monitored for an additional year to assess safety and effectiveness.

What are the potential side effects?

Potential side effects may include typical reactions to immunotherapy such as fatigue, nausea, skin reactions; chemo-related hair loss (alopecia), nerve damage (neuropathy); plus risks of infection due to lowered immune response from both drug types.

Eligibility Criteria

Inclusion Criteria

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

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My side effects from the last chemotherapy are mostly gone, except for hair loss and nerve issues.

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I am fully active and can carry on all pre-disease activities without restriction.

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My cancer can be measured by scans.

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I am 18 years old or older.

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My pancreatic cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

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

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I have not received a live vaccine in the last 30 days.

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I have an immune system disorder or have taken steroids in the past week.

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I have been treated with drugs targeting PD-1, PD-L1, or PD-L2.

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My pancreatic tumor is not adenocarcinoma.

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I haven't had cancer treatment with monoclonal antibodies in the last 4 weeks or still have side effects from them.

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I have a blockage in my intestines.

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I have not needed treatment for an autoimmune disease in the last 2 years.

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I have another cancer that is getting worse or needs treatment.

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I do not have an active or uncontrolled infection requiring treatment.

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I have a history of Chronic Hepatitis B or C.

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I have had pneumonitis treated with steroids or have it now.

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I have cancer that has spread to my brain or spinal cord.

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My condition can be treated with the goal of curing it.

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I haven't had cancer treatment or recovered from its side effects in the last 2 weeks.

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I have a history of lung scarring or fibrosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 8 weeks until eot, for up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 8 weeks until eot, for up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks until eot, for 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

Objective Response Rate

Secondary study objectives

Disease Control Rate

Grade 3-5 Treatment-related Toxicity Rate

Median Duration of Overall Response (DOR)

+2 more

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: COHORT 2: AGEN1423 Plus Botensilimab and ChemotherapyExperimental Treatment4 Interventions

Treatment is AGEN1423 plus Botensilimab in combination with gemcitabine and nab-paclitaxel for 2 cycles (8 weeks) followed by Botensilimab in combination with gemcitabine and nab-paclitaxel for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered once every 2 weeks.

Group II: COHORT 1: AGEN1423 Plus BotensilimabExperimental Treatment2 Interventions

Treatment is AGEN1423 plus Botensilimab for 4 cycles (8 weeks) followed by Botensilimab alone for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Botensilimab will be administered every 2 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Gemcitabine

2017

Completed Phase 3

~1920

Nab-paclitaxel

2014

Completed Phase 3

~1950

0 / 20Eligibility 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

Common treatments for pancreatic cancer include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy agents like gemcitabine and nab-paclitaxel work by interfering with the DNA replication of cancer cells, leading to cell death. Immunotherapy, such as Balstilimab (an anti-PD-1 antibody), enhances the immune system's ability to recognize and destroy cancer cells by blocking the PD-1 pathway, which tumors use to evade immune detection. Novel agents like AGEN1423 may target specific pathways or mechanisms within cancer cells to inhibit their growth. Additionally, PARP inhibitors are used in patients with specific genetic mutations (e.g., BRCA) to exploit the cancer cells' impaired DNA repair mechanisms, leading to cell death. These treatments are crucial for pancreatic cancer patients as they offer multiple avenues to attack the cancer, potentially improving outcomes and providing options when the disease progresses after initial therapies.