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Monoclonal Antibodies
HCW9218 for Pancreatic Cancer
Phase 1 & 2
Waitlist Available
Research Sponsored by HCW Biologics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized)
Age > 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new drug for pancreatic cancer.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic pancreatic cancer that's worsened after standard therapy, or those who can't tolerate first-line treatments. They must have a life expectancy of at least 12 weeks and be able to use birth control. People with significant recent vascular disease, HIV/AIDS, ongoing treatment side effects (except certain conditions), psychiatric issues affecting compliance, untreated brain metastases, or known allergies to similar drugs are excluded.Check my eligibility
What is being tested?
The study tests HCW9218 in two phases: an initial dose-escalation phase for patients not eligible for surgery due to advanced disease and a later expansion phase focused on those with distant metastatic disease only. It's an open-label trial where everyone knows what treatment they're getting.See study design
What are the potential side effects?
While specific side effects of HCW9218 aren't listed here, Phase 1 trials often look out for any signs of toxicity such as nausea, fatigue, allergic reactions or more serious complications related to the drug being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and have had a negative pregnancy test within the last 14 days.
Select...
I am older than 18 years.
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My lung function is more than half of what is expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine the maximum tolerated dose (MTD)
Occurrence of Adverse Events and Treatment-Related Adverse Events
Secondary outcome measures
Duration of Response
Objective Response Rate (ORR)
Overall Survival (OS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: HCW9218Experimental Treatment1 Intervention
Experimental Arm: HCW9218
Find a Location
Who is running the clinical trial?
HCW BiologicsLead Sponsor
Pallavi ChaturvediStudy DirectorHCW Biologics
Danieska SandinoStudy DirectorHCW Biologics
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had an organ transplant from another person.My pancreatic cancer is advanced, cannot be surgically removed, and has not responded to or cannot tolerate standard treatments.I am currently on IV antibiotics for an infection.I am not pregnant and have had a negative pregnancy test within the last 14 days.You have been diagnosed with HIV or AIDS.You are expected to live for at least 12 more weeks.I am not taking any herbal or unconventional therapies.I have treated brain metastases and have been stable without steroids or on a low dose for 2 weeks.I am using or agree to use birth control during and after the trial.I haven't had any cancer treatments, including surgery or chemotherapy, in the last 14 days.I have previously been treated with TGF-β antagonist or IL-15.I am on high-dose steroids or immunosuppressants for an autoimmune disease.Before starting treatment, your recent blood tests should show: a certain level of white blood cells, a certain level of platelets, a certain level of hemoglobin, and specific levels of kidney and liver function.I don't have lasting side effects from cancer treatment that would affect new treatment, except for nerve issues, hair loss, or tiredness.In the first part of the study, you have advanced cancer that cannot be removed with surgery. In the second part, you have cancer that has spread to other parts of the body.I haven't had any major blood vessel problems in the last 6 months.I am not pregnant or nursing.I am older than 18 years.Your heart's electrical activity shows a long QT interval, which can be a risk for certain medications.My cancer has spread far and cannot be surgically removed.I have no cancer history except for certain skin cancers, early-stage cancers I've recovered from, or any cancer I've been free of for 3 years.You have had allergic reactions to similar drugs in the past.I had radiation therapy, but my current cancer area wasn't treated or has worsened since.My lung function is more than half of what is expected.
Research Study Groups:
This trial has the following groups:- Group 1: HCW9218
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.
Is enrollment for this experiment still open to volunteers?
"According to clinicaltrials.gov, this medical trial is still in need of patients; the initial post was published on October 17th 2022 and the information was last updated four days later."
Answered by AI
What goal is this research endeavor aiming to accomplish?
"This medical experiment seeks to discover the Maximum Tolerated Dose (MTD) of a certain drug over its 12 month timeframe. Secondary objectives include evaluating Objective Response Rate according to RECIST 1.1, measuring Overall Survival from first administration until death due to any cause, and determining Duration of Response which is calculated as the time between response and progression or mortality."
Answered by AI
What is the maximum number of participants being accepted into this medical research?
"Correct. Clinicaltrials.gov states that this medical experiment, which was initially shared on October 17th 2022, is actively searching for candidates. Around 60 participants need to be enrolled from 2 appointed centres."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Medical University of South Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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