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Odetiglucan + CD40 Agonist for Pancreatic Cancer
Phase 1
Waitlist Available
Research Sponsored by HiberCell, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 months of last patient enrolled
Awards & highlights
No Placebo-Only Group
Summary
This trialwill test a new drug combo to treat advanced pancreatic cancer, assessing safety, effectiveness and side effects.
Who is the study for?
This trial is for adults with metastatic pancreatic cancer who've had a positive response or stable disease after 16-32 weeks of chemotherapy. They must have specific blood antibody levels, be in good physical condition (ECOG 0 or 1), and have normal organ function tests. Women must not be pregnant and agree to use contraception.
What is being tested?
The study aims to find the safest dose for odetiglucan combined with CDX-1140, assessing its safety and tolerability. Up to 45 patients will participate, looking at how their bodies handle the drugs and any potential toxic effects at different doses.
What are the potential side effects?
Potential side effects include reactions related to drug infusion, changes in blood counts that could affect immunity or clotting, liver enzyme alterations suggesting liver stress, kidney function changes, and possibly other organ inflammation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 24 months of last patient
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 24 months of last patient
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose
Secondary study objectives
Duration of Response
Median Overall Survival and Overall Survival at 1 Year
Median Progression Free Survival and Progression Free Survival at 6 Months
+1 moreAwards & 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: Part BExperimental Treatment2 Interventions
Patients will have regularly scheduled study visits on day 1 of each cycle. On Day 1 patients will receive odetiglucan and CDA-1140. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year.
Group II: Part AExperimental Treatment2 Interventions
Patients will have regularly scheduled study visits on days 1, 8, and 15 of each cycle. On Day 1 patients will receive odetiglucan and CDX-1140. On Days 8 \& 15 only odetiglucan. Additional study visits may be required during some cycles for safety, efficacy, and translational assessments. Patients will dose to confirmed progression, a safety event or other administrative reason requiring discontinuation; all patients are allowed to dose up to 2 years (patients continuing to derive benefit may stay on treatment longer following consultation between Investigator and Sponsor). Following discontinuation patients will be followed up to 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CDX-1140
2017
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
HiberCell, Inc.Lead Sponsor
19 Previous Clinical Trials
875 Total Patients Enrolled
Celldex TherapeuticsIndustry Sponsor
64 Previous Clinical Trials
5,797 Total Patients Enrolled
Mark O'HaraStudy ChairUniversity of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function tests are within the required range.I've had 16-32 weeks of first-line chemotherapy with no cancer progression.I have never been treated with CD40 antibodies or similar immune-based treatments for cancer.My blood clotting time is normal or managed with medication.I do not have a known or suspected spinal cord or brain lining disease.I have a history of HIV, hepatitis B, or hepatitis C.I am over 18, understand the study, and agree to all its requirements.I am using corticosteroids that don't significantly enter my bloodstream.I have been treated with odetiglucan before.I have not had chemotherapy in the last 14 days.I had hepatitis C but it's now undetectable.I am fully active or restricted in physically strenuous activity but can do light work.I am taking low-dose steroids, not more than 10 mg of prednisone.I do not have any severe illnesses like heart failure, uncontrolled diabetes, or serious infections.I have not had a heart attack or blood clot in the arteries in the last 6 months.I have not had major surgery within the last 4 weeks.I may need steroids, but it depends on my doctor's approval.I haven't had a live vaccine in the last 28 days and won't get one during or for 30 days after the study.I've been cancer-free for 3 years, except for minor skin cancers or in situ cancers.I can understand and am willing to sign the consent form.My pancreatic cancer has spread and was confirmed by a lab test.My blood clotting time is within safe limits, or I'm stable on my blood thinner with no bleeding.All my side effects from chemotherapy have gone except for hair loss and mild nerve pain.I have antibodies against hepatitis B but no active virus.I have brain metastases that haven't been treated.I am not pregnant, breastfeeding, nor planning to become pregnant during the study.I have or had lung inflammation not caused by an infection.I haven't taken immunosuppressive drugs in the last 14 days, except for allowed exceptions.I have not needed systemic treatment for an autoimmune disease in the last 2 years.I agree to use two effective birth control methods if I'm of childbearing potential or with someone who is.
Research Study Groups:
This trial has the following groups:- Group 1: Part B
- Group 2: Part A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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