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AGEN1423 + Balstilimab With/Without Chemo for Pancreatic Cancer

Phase 2
Waitlist Available
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

Summary

This trial will assess the safety and effectiveness of a combination of AGEN1423 and Balstilimab in advanced pancreatic cancer which has progressed after one or more treatments.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate
Secondary outcome measures
Disease Control Rate
Grade 3-5 Treatment-related Toxicity Rate
Median Duration of Overall Response (DOR)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: COHORT 2: AGEN1423 Plus Balstilimab and ChemotherapyExperimental Treatment4 Interventions
Treatment is AGEN1423 plus balstilimab in combination with gemcitabine and nab-paclitaxel for 2 cycles (8 weeks) followed by balstilimab in combination with gemcitabine and nab-paclitaxel for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Balstilimab will be administered once every 2 weeks.
Group II: COHORT 1: AGEN1423 Plus BalstilimabExperimental Treatment2 Interventions
Treatment is AGEN1423 plus balstilimab for 4 cycles (8 weeks) followed by balstilimab alone for up to 2 years. AGEN1423 will be administered in a total of 4 doses. Balstilimab will be administered every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Nab-paclitaxel
2014
Completed Phase 3
~2030

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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteOTHER
1,085 Previous Clinical Trials
341,756 Total Patients Enrolled
Bruno BockornyLead Sponsor
Bruno Bockorny, MDLead Sponsor

Media Library

AGEN1423 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05632328 — Phase 2
Pancreatic Cancer Research Study Groups: COHORT 1: AGEN1423 Plus Balstilimab, COHORT 2: AGEN1423 Plus Balstilimab and Chemotherapy
Pancreatic Cancer Clinical Trial 2023: AGEN1423 Highlights & Side Effects. Trial Name: NCT05632328 — Phase 2
AGEN1423 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05632328 — Phase 2
~16 spots leftby May 2026