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Monoclonal Antibodies
Evofosfamide + Zalifrelimab + Balstilimab for Prostate Cancer
Houston, TX
Phase 1 & 2
Recruiting
Research Sponsored by ImmunoGenesis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically confirmed locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative SCCHN with no other lines of standard therapy available
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Must not have
Concomitant use of strong or moderate CYP3A4 inhibitors or inducers
Concomitant use of anti-cancer therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of new drugs to see how safe and effective they are in treating advanced prostate cancer, pancreatic cancer, and some types of head and neck cancer.
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Who is the study for?
This trial is for adults with advanced prostate, pancreatic, or HPV-negative head and neck cancers without standard treatment options. Participants must have a life expectancy of at least 3 months, measurable disease, good organ function, and an ECOG status of 0-2. They should not be on certain drugs that affect the immune system or have uncontrolled diseases.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of combining evofosfamide with zalifrelimab and balstilimab in treating specific advanced cancers. It's a Phase 1/2 trial where patients receive all three investigational drugs to see how well they work together.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as inflammation in various organs, fatigue, digestive issues like nausea or diarrhea, skin reactions, potential liver toxicity, and increased risk of infections due to immune modulation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced, resistant to hormone therapy, and has no standard treatments left.
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I can take care of myself and am up and about more than half of my waking hours.
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My kidney function, measured by creatinine clearance, is good.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking strong or moderate drugs that affect liver enzyme CYP3A4.
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I am not using any other cancer treatments.
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I have an active autoimmune disease that is not under control.
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I've had severe side effects from certain treatments.
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I have a history of stomach or intestine problems.
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I have been using steroids for a long time.
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I have risk factors for a specific heart rhythm problem.
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I have an active HIV infection.
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My cancer has spread to my brain and hasn't been treated yet.
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I have had a major surgery or serious injury recently.
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I do not have any active or uncontrolled infections or diseases.
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I have an active or chronic hepatitis B or C infection.
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I am currently receiving specific immunotherapy treatments.
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I am not taking any medications that affect my heart's rhythm.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: Pancreatic cancerExperimental Treatment3 Interventions
Evofosfamide + zalifrelimab + balstilimab
Group II: Human papilloma virus-negative squamous cell carcinoma of the head and neckExperimental Treatment3 Interventions
Evofosfamide + zalifrelimab + balstilimab
Group III: Castration-resistant prostate cancerExperimental Treatment3 Interventions
Evofosfamide + zalifrelimab + balstilimab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zalifrelimab
2016
Completed Phase 2
~90
Evofosfamide
2013
Completed Phase 1
~20
Balstilimab
2023
Completed Phase 1
~20
Find a Location
Closest Location:MD Anderson Cancer Center· Houston, TX· 571 miles
Who is running the clinical trial?
ImmunoGenesisLead Sponsor
2 Previous Clinical Trials
140 Total Patients Enrolled
Agenus Inc.Industry Sponsor
57 Previous Clinical Trials
4,819 Total Patients Enrolled
2 Trials studying Prostate Cancer
499 Patients Enrolled for Prostate Cancer