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Anti-metabolites
Zolbetuximab + Chemotherapy for Pancreatic Cancer
Phase 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject has a measurable lesion(s) on at least 1 metastatic site based on RECIST 1.1 within 28 days prior to randomization. For subjects with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.
Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Must not have
Subject has significant cardiovascular disease, including: Congestive heart failure (defined as New York Heart Association Class III or IV), myocardial infarction, unstable angina, coronary angioplasty, coronary stenting, coronary artery bypass graft, cerebrovascular accident or hypertensive crisis within 6 months prior to randomization; History of clinically significant ventricular arrhythmias (i.e., sustained ventricular tachycardia, ventricular fibrillation or Torsades de Pointes); QTc interval > 450 msec for male subjects; QTc interval > 470 msec for female subjects; Cardiac arrhythmias requiring anti-arrhythmic medications (Subjects with rate controlled atrial fibrillation for > 1 month prior to randomization.)
Subject has pleural effusion or ascites ≥ Grade 3.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 65 months
Awards & highlights
Summary
This trial is testing a new cancer treatment and will measure how well it works, how long patients live, and how safe it is.
Who is the study for?
This trial is for adults with metastatic pancreatic adenocarcinoma that tests positive for CLDN18.2 and haven't had chemotherapy before. They should have a life expectancy of at least 12 weeks, be able to follow contraceptive guidelines, and not be pregnant or breastfeeding. People who've had certain recent treatments or surgeries, active infections, other cancers needing treatment, severe allergies to study drugs' components, or specific heart conditions can't join.
What is being tested?
The trial is testing the effectiveness and safety of a drug called zolbetuximab combined with Nab-Paclitaxel and Gemcitabine as the first line of treatment. It aims to confirm the best dose for phase 2 trials, measure how long patients live while on this treatment, monitor side effects, check how their bodies process the drugs (pharmacokinetics), and assess any changes in their quality of life.
What are the potential side effects?
Possible side effects include reactions related to zolbetuximab infusion such as fever or chills; blood disorders like low white cell counts increasing infection risk; fatigue; digestive issues from nausea to diarrhea; potential liver enzyme changes; nerve damage causing numbness or tingling; allergic reactions; and possibly others not listed.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a tumor that can be measured and it's either outside the area treated with radiation or has grown after radiation.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.
Select...
My tumor shows high CLDN18.2 expression.
Select...
My pancreatic cancer has spread and I haven't had chemotherapy.
Select...
My cancer is a type of pancreatic cancer called adenocarcinoma.
Select...
I will not donate eggs during and for 6 months after the study.
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My condition did not worsen after treatment with Nab-P and GEM.
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My condition did not worsen after treatment with Nab-P and GEM.
Select...
My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).
Select...
My liver function tests are within the required range.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have serious heart issues or had a major heart event in the last 6 months.
Select...
I have severe fluid buildup in my chest or abdomen.
Select...
I do not have active hepatitis B according to my test results.
Select...
I was treated for hepatitis C and now have no detectable virus.
Select...
My pancreatic cancer has spread to my brain or its coverings.
Select...
I am allergic to zolbetuximab or similar medications.
Select...
I have not fully recovered from a major surgery within the last 2 weeks.
Select...
I need treatment for another type of cancer.
Select...
I had radiation for pancreatic cancer less than 2 weeks ago and still have side effects.
Select...
I have had interstitial pneumonia or pulmonary fibrosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 65 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 65 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicities (DLT) - (safety lead in)
Number of participants with Eastern Cooperative Oncology Group (ECOG) performance status abnormalities and or adverse events
Number of participants with electrocardiograms (ECG) abnormalities and or adverse events
+6 moreSecondary study objectives
Change in CA (Cancer Antigen) 19-9
Disease Control Rate (DCR)
Duration Of Response (DOR)
+29 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: zolbetuximab +nab-paclitaxel + gemcitabineExperimental Treatment3 Interventions
Participants will be treated with zolbetuximab in combination with nab-paclitaxel and gemcitabine for the phase 1 portion of the study to establish the recommended dose of zolbetuximab for the phase 2 portion. In the phase 2 portion, the participants will be treated with zolbetuximab at dose determined by the phase 1 portion of the study in combination with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Group II: nab-paclitaxel + gemcitabineActive Control2 Interventions
Participants will be treated with nab-paclitaxel and gemcitabine. Participants will be treated on continuous cycles until they no longer derive clinical benefit in the judgment of the treating physician, have unacceptable toxicity, undergo hematopoietic stem cell transplantation (HSCT), or meet one of the discontinuation criteria; whichever occurs first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
zolbetuximab
2019
Completed Phase 2
~270
nab-paclitaxel
2008
Completed Phase 4
~1430
gemcitabine
2013
Completed Phase 3
~4260
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
199 Previous Clinical Trials
122,284 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development
2,834 Previous Clinical Trials
8,079,387 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor that can be measured and it's either outside the area treated with radiation or has grown after radiation.I have severe fluid buildup in my chest or abdomen.You can participate in the study if your hepatitis C blood test shows that you had the infection in the past, but the virus is not currently in your body.I do not have active hepatitis B according to my test results.Your albumin levels are at least 2.5 grams per deciliter.I was treated for hepatitis C and now have no detectable virus.I am fully active or restricted in physically strenuous activity but can do light work.Your total bilirubin level in the blood should be less than 1.5 times the upper limit of normal.My pancreatic cancer has spread to my brain or its coverings.You have tested positive for HIV, hepatitis B, or hepatitis C.I agree not to breastfeed during and for 6 months after the study.I have had fluorouracil or GEM with radiation therapy.My cancer returned or got worse 6 months after finishing my last cancer prevention treatment.I am allergic to zolbetuximab or similar medications.My tumor shows high CLDN18.2 expression.I have moderate to severe nerve damage in my hands or feet, not just from missing reflexes.I have not fully recovered from a major surgery within the last 2 weeks.My pancreatic cancer has spread and I haven't had chemotherapy.I need treatment for another type of cancer.I will not donate sperm during or for 6 months after the study.My cancer is a type of pancreatic cancer called adenocarcinoma.I haven't taken strong immune system suppressing drugs in the last 14 days, except for low-dose steroids or a one-time use.I have serious heart issues or had a major heart event in the last 6 months.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.I had radiation for pancreatic cancer less than 2 weeks ago and still have side effects.Your hemoglobin level is at least 9 grams per deciliter, and you have not had a blood transfusion in the past 14 days.Your white blood cell count is at least 1.5 x 10^9/L.I will not donate eggs during and for 6 months after the study.I am not pregnant or breastfeeding and either cannot become pregnant or will follow birth control guidelines for 6 months after the study.My condition did not worsen after treatment with Nab-P and GEM.I have had interstitial pneumonia or pulmonary fibrosis.My condition did not worsen after treatment with Nab-P and GEM.Your blood clotting time is within a certain range, unless you are already taking medication to prevent blood clots.I have an autoimmune disease and have received treatment for it in the last 3 months.My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).I am a man who will use birth control during and for 6 months after the study.I have an infection needing treatment that hasn't fully cleared in the last week.I had major surgery less than 28 days ago.I have received 5-FU or GEM with radiation therapy.Your platelet count is at least 100 billion per liter.My liver function tests are within the required range.
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.
Research Study Groups:
This trial has the following groups:- Group 1: zolbetuximab +nab-paclitaxel + gemcitabine
- Group 2: nab-paclitaxel + gemcitabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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