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Peptidomimetic
ProAgio for Advanced Pancreatic Cancer
Phase 1
Recruiting
Led By Christine Alewine, MD, PhD
Research Sponsored by ProDa BioTech, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically or cytologically confirmed diagnosis of a solid tumor malignancy for which no curative therapy exists as confirmed by the NCI Laboratory of Pathology
ECOG performance status <2 (Karnofsky >60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
Study Summary
This trial is testing a new cancer drug to see if it is safe for people with advanced pancreatic cancer.
Who is the study for?
This trial is for adults over 18 with advanced solid tumors, including pancreatic cancer, who've had at least one prior treatment. They must have a tumor that can be biopsied or measurable disease and good organ function. Participants need to use contraception and cannot join if they're pregnant, have significant uncontrolled diseases, active infections, recent surgery or radiation therapy, untreated brain metastases, certain blood pressure or heart rate conditions.Check my eligibility
What is being tested?
The study tests the safety of different dose levels of ProAgio in patients with various advanced solid tumors. It's a first-in-human Phase I trial where participants are given escalating doses to find out how much of this new drug can be safely administered.See study design
What are the potential side effects?
As this is an early-phase trial for ProAgio, specific side effects aren't listed but generally could include typical reactions to cancer drugs such as fatigue, nausea, risk of infection due to immune system impact; organ-specific inflammation; allergic reactions; and potential impacts on blood pressure or heart rhythm.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is confirmed and cannot be cured, according to a pathology lab.
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I can take care of myself but may not be able to do heavy physical work.
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I am older than 18 years.
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My blood pressure is under control, my heart's QT interval is normal, and my resting heart rate is between 45 and 100 bpm.
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My blood and organ functions are within the required ranges for the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Assess serum tumor marker CA19-9 or appropriate tumor specific marker.
Disease control rate (DCR).
Evaluate the Maximum Plasma Concentration of ProAgio
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Standard ArmExperimental Treatment2 Interventions
Participants will receive ProAgio at the RP2D.
Group II: Dose EscalationExperimental Treatment3 Interventions
Participants will receive ProAgio in escalating doses.
Group III: Biopsy ArmExperimental Treatment3 Interventions
Participants will receive ProAgio at the RP2D and undergo tumor biopsy.
Find a Location
Who is running the clinical trial?
ProDa BioTech, LLCLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,796 Total Patients Enrolled
Christine Alewine, MD, PhDPrincipal InvestigatorNational Cancer Institute (NCI)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is confirmed and cannot be cured, according to a pathology lab.I have been diagnosed with a primary brain tumor.I can take care of myself but may not be able to do heavy physical work.I do not have any active or uncontrolled infections.I have not had uncontrolled bleeding in the last 28 days.I am willing and able to have a biopsy for my condition.I had radiation therapy less than 14 days ago.I agree to use effective birth control during and for 3 months after the study.You have HIV and your viral load is detectable.I am older than 18 years.I have not had minor surgery in the last 14 days or major surgery in the last 28 days.I have a chronic neurological disorder that affects my movement, vision, or causes seizures.I have not had a stroke, heart attack, or blood clot in the last 28 days.I have a blood clotting disorder and am not on a stable medication regimen.My pancreatic cancer is confirmed and not purely neuroendocrine.My disease can be measured or tracked through exams, tests, or scans.Participants in the expansion group must have a way to measure their disease according to certain guidelines.My blood pressure is under control, my heart's QT interval is normal, and my resting heart rate is between 45 and 100 bpm.I do not have any major health issues that could interfere with the study.I have had Hepatitis B or C in the past.I have brain metastases or leptomeningeal disease and have recently needed steroids or anti-seizure medication.I have had at least one treatment for my advanced disease and it's been over 14 days since my last treatment.My blood and organ functions are within the required ranges for the trial.
Research Study Groups:
This trial has the following groups:- Group 1: Biopsy Arm
- Group 2: Dose Escalation
- Group 3: Standard Arm
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the aggregate quantity of individuals signing up for this clinical investigation?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial, which commenced on October 29th 2021, is presently recruiting patients - 58 subjects need to be sourced from 1 location."
Answered by AI
What risks may arise from the intake of ProAgio?
"Limited clinical data exists to support the efficacy and safety of ProAgio, resulting in a rating of 1 on Power's scale."
Answered by AI
Are there any openings still available for participants in this investigation?
"Data presented on clinicaltrials.gov demonstrates this medical trial is actively recruiting volunteers, with the study's inception date being October 29th 2021 and its most recent update occuring September 26th 2022."
Answered by AI
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