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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

No Placebo-Only Group

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 below

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I have a tumor that can be measured and it's either outside the area treated with radiation or has grown after radiation.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.

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My tumor shows high CLDN18.2 expression.

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My pancreatic cancer has spread and I haven't had chemotherapy.

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My cancer is a type of pancreatic cancer called adenocarcinoma.

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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.

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My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).

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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:

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I have serious heart issues or had a major heart event in the last 6 months.

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I have severe fluid buildup in my chest or abdomen.

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I do not have active hepatitis B according to my test results.

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I was treated for hepatitis C and now have no detectable virus.

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My pancreatic cancer has spread to my brain or its coverings.

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I am allergic to zolbetuximab or similar medications.

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I have not fully recovered from a major surgery within the last 2 weeks.

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I need treatment for another type of cancer.

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I had radiation for pancreatic cancer less than 2 weeks ago and still have side effects.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 65 months for reporting.

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 more

Secondary study objectives

Change in CA (Cancer Antigen) 19-9

Disease Control Rate (DCR)

Duration Of Response (DOR)

+29 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~1420