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Chemotherapy
Zolbetuximab Combination Therapy for Stomach Cancer (ILUSTRO Trial)
Phase 2
Recruiting
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
Cohorts 1-4: Estimated creatinine clearance ≥ 30 mL/min
Cohort 5: Serum creatinine ≤ 1.5 × ULN, or estimated creatinine clearance ≥ 50 mL/min for subjects with serum creatinine levels > 1.5 × ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 months
Awards & highlights
ILUSTRO Trial Summary
This trial is testing the effects of zolbetuzimab on different types of cancer. The study will assess how well the drug works on its own and in combination with other drugs, as well as its side effects. Additionally, the trial will look at how the drug affects the quality of life of patients and how long patients respond to the treatment.
Who is the study for?
This trial is for adults with advanced or metastatic gastric or GEJ adenocarcinoma that tests positive for CLDN18.2. They should have a life expectancy of at least 12 weeks, meet specific lab criteria, and agree to contraception if applicable. Exclusions include severe allergies to similar drugs, recent immunosuppressive therapy, significant heart issues within the past 6 months, active infections requiring systemic treatment, other cancers needing treatment, and certain psychiatric or social conditions.Check my eligibility
What is being tested?
The study is testing Zolbetuximab's effectiveness alone and in combination with chemotherapy (mFOLFOX6) plus/minus Nivolumab or Pembrolizumab on tumor response rate and progression-free survival. It will also assess safety/tolerability, effects on CLDN18.2 expression levels, pharmacokinetics of all drugs involved, quality of life impacts from treatments provided.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to Zolbetuximab or other monoclonal antibodies used in the trial; complications related to oxaliplatin such as nerve damage; digestive issues from fluorouracil; immune-related adverse events due to Pembrolizumab/Nivolumab like inflammation in organs; fatigue; increased risk of infection.
ILUSTRO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).
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My kidney function is within the required range.
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I haven't had any drug treatments for my advanced cancer.
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My tumor shows high CLDN18.2 expression.
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My tumor tests positive for CLDN18.2 with moderate to strong levels.
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My advanced disease has worsened after at least 2 treatments, including chemotherapy.
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I have never received checkpoint inhibitor therapy.
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I have been diagnosed with stomach or gastroesophageal junction cancer.
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My advanced disease has worsened after 2 treatments, including chemotherapy.
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My stomach cancer is not HER2 positive.
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My stomach or gastroesophageal cancer is at a specific stage and size, not spread far.
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I am fully active or restricted in physically strenuous activity but can do light work.
ILUSTRO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 72 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) of zolbetuximab as a single agent by central review (Cohort 1)
Secondary outcome measures
DCR of zolbetuximab as a single agent by independent central reader (Cohort 1A)
DCR of zolbetuximab in combination with mFOLFOX6 (with nivolumab) by investigator assessment (Cohort 4)
DCR of zolbetuximab in combination with mFOLFOX6 by Independent central reader (Cohort 2)
+70 moreILUSTRO Trial Design
5Treatment groups
Experimental Treatment
Group I: zolbetuximab (Cohort 1A)Experimental Treatment1 Intervention
Participants will be treated with zolbetuximab on a 21-day cycle in which zolbetuximab will be administered as a single agent every 3 weeks until disease progression, toxicity requiring cessation, start of another anti-cancer treatment or other treatment discontinuation criteria are met.
Group II: mFOLFOX6 plus zolbetuximab (Cohort 2)Experimental Treatment5 Interventions
Participants will be treated with zolbetuximab and mFOLFOX6 on a 42-day cycle in which zolbetuximab is administered on days 1 and 22, and mFOLFOX6 is administered on days 1, 15 and 29; however, for the first cycle, zolbetuximab will be administered on day 3 (instead of day 1) to allow for pharmacokinetic collection. Participants will receive up to 12 mFOLFOX6 treatments (4 cycles). Beginning at cycle 5, participants may continue on 5-FU and leucovorin or folinic acid along with zolbetuximab for the remainder of the study per investigator's discretion. mFOLFOX6 treatment includes oxaliplatin: intravenous [IV] infusion, leucovorin: IV infusion, fluorouracil bolus: IV bolus, fluorouracil infusion: continuous IV infusion.
Group III: Zolbetuximab in combination with mFOLFOX6 and nivolumab (Cohort 4A/4B)Experimental Treatment6 Interventions
Participants will be treated with zolbetuximab and mFOLFOX6, nivolumab on a 42-day cycle. Cohort 4A: Loading dose of zolbetuximab in combination with nivolumab and mFOLFOX6 on cycle 1 day 1, followed by zolbetuximab in combination with nivolumab and mFOLFOX6 q2w [days 15 and 29] (1 cycle = 6 weeks). Tolerability and safety of zolbetuximab in combination with nivolumab, mFOLFOX6 will be evaluated during the 3-week DLT assessment period. If cycle 1 dose is not tolerable, a lower dose of dose zolbetuximab in combination with nivolumab and mFOLFOX6 will be subsequently evaluated. Cohort 4B: Subjects will be treated with the combination of zolbetuximab, mFOLFOX6 and nivolumab at the dose deemed tolerable in Cohort 4A. Subjects will receive up to 12 mFOLFOX6 treatments (4 cycles). For Cohorts 4A and 4B, beginning at cycle 5, subjects may continue on 5-FU and leucovorin or folinic acid along with zolbetuximab and nivolumab for the remainder of the study per investigator's discretion.
Group IV: Zolbetuximab in combination with FLOT (Cohort 5)Experimental Treatment6 Interventions
Participants will be treated with zolbetuximab & FLOT for a total of eight 2-week cycles. 4 cycles preoperatively & 4 cycles postoperatively 6-12 weeks after surgery.
Preoperative: Participants will receive zolbetuximab loading dose on cycle 1 day 1, followed by FLOT on cycle 1 day 2. For cycles 2-4, participants may receive zolbetuximab maintenance dose in combination with FLOT, dosed on day 1 of each cycle. However, dosing may be split over 2 days with zolbetuximab administration on day 1 & FLOT on day 2.
Post operative: Participants will receive zolbetuximab loading dose on cycle 5 day 1, followed by FLOT on cycle 5 day 2. For cycles 6-8, participants may receive zolbetuximab maintenance dose in combination with FLOT, dosed on day 1 of each cycle. However, dosing may be split over 2 days with zolbetuximab administration on day 1 and FLOT on day 2. For participants who experience a DLT during preoperative treatment on the loading dose, the postoperative loading dose may be lowered.
Group V: Pembrolizumab plus zolbetuximab (Cohort 3A)Experimental Treatment2 Interventions
Participants will be treated with zolbetuximab and pembrolizumab on a 21-day cycle. Loading dose of zolbetuximab will be administered at cycle 1, day 1 followed by maintenance dose of zolbetuximab once every 3 weeks (Q3W). Pembrolizumab will be administered to 3 to 6 subjects at a intravenously on day 1 of every 21-day cycle and will be infused 1 hour after the zolbetuximab infusion is completed. Tolerability and safety of zolbetuximab in combination with pembrolizumab will be evaluated during the 3-week dose-limiting toxicity (DLT) assessment period. If this cycle 1 dose is not tolerable, a lower dose of zolbetuximab in combination with pembrolizumab will subsequently be evaluated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
zolbetuximab
2019
Completed Phase 2
~270
oxaliplatin
2002
Completed Phase 3
~6370
leucovorin
2005
Completed Phase 3
~1200
fluorouracil
1994
Completed Phase 3
~8440
Pembrolizumab
2017
Completed Phase 2
~2010
folinic acid
2009
Completed Phase 3
~580
nivolumab
2016
Completed Phase 3
~4960
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,943 Total Patients Enrolled
Global Medical LeadStudy DirectorAstellas Pharma Global Development, Inc.
4 Previous Clinical Trials
682 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken any immune-weakening medication, including steroids, in the last 14 days.My cancer can be measured and was checked within the last 28 days.I agree to use contraception for 6 months after my last treatment.I have an autoimmune disease treated within the last 3 months.I had radiotherapy for stomach cancer less than 14 or 28 days ago and still feel side effects.I have another cancer that needs treatment.My tumor is identified as MSI-High or has mismatch repair deficiency.My liver function tests are within the required range.My kidneys are working well enough (creatinine clearance ≥ 30 mL/min).My kidney function is within the required range.My cancer can be measured and was checked within the last 28 days.I haven't had any drug treatments for my advanced cancer.I have a recent tumor sample taken within the last 3 months.I am willing and able to undergo tumor biopsies as needed for the study.I have a new diagnosis of stomach or GEJ cancer that can be surgically removed.My tumor shows high CLDN18.2 expression.I have severe or partial blockage in my stomach causing vomiting.I do not have severe stomach bleeding or untreated stomach ulcers.I am not pregnant and either cannot become pregnant or will follow birth control guidelines during and after treatment.I agree not to donate sperm from now until 6 months after my last treatment.My stomach cancer is not HER2 positive.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.I have been diagnosed with stomach or gastroesophageal junction cancer.My advanced disease has worsened after 2 treatments, including chemotherapy.I have a recent tumor sample taken within the last 3 months.My stomach or gastroesophageal cancer is local and can be surgically removed.My stomach or gastroesophageal cancer is at a specific stage and size, not spread far.My cancer has spread to my brain or its coverings from my stomach.I have tested positive for HIV or active hepatitis B or C.I have an infection needing treatment that hasn't cleared in the last week.I have not had major surgery in the last 28 days.I cannot have surgery to cure my condition, or my cancer is in an early stage (cT1N0).My tumor tests positive for CLDN18.2 with moderate to strong levels.My disease can be measured by scans according to specific criteria, and was assessed within the last 28 days.I have a history of autoimmune disease, lung disease, serious allergies to pembrolizumab or nivolumab, or other significant health issues.My advanced disease has worsened after at least 2 treatments, including chemotherapy.I have never received checkpoint inhibitor therapy.I haven't had systemic anti-cancer therapy for my advanced disease, but may have had certain chemotherapies over 6 months ago.I am willing and able to have a tumor biopsy.I haven't had serious heart issues like a heart attack or unstable angina in the last 6 months.I had major surgery less than 2 weeks ago and haven't fully recovered.I've had severe allergic reactions to specific cancer drugs before.I am fully active or restricted in physically strenuous activity but can do light work.
Research Study Groups:
This trial has the following groups:- Group 1: Zolbetuximab in combination with FLOT (Cohort 5)
- Group 2: zolbetuximab (Cohort 1A)
- Group 3: mFOLFOX6 plus zolbetuximab (Cohort 2)
- Group 4: Pembrolizumab plus zolbetuximab (Cohort 3A)
- Group 5: Zolbetuximab in combination with mFOLFOX6 and nivolumab (Cohort 4A/4B)
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 zolbetuximab's standing with the FDA?
"Zolbetuximab's safety is estimated to be a 2. This is because, while there is evidence that it is safe, there is no data yet supporting that it actually works."
Answered by AI
What are zolbetuximab's traditional indications?
"zolbetuximab is the standard of care for unresectable melanoma. zolbetuximab has also shown to be an effective treatment option against microsatellite instability high, squamous cell carcinoma, and rectal carcinoma."
Answered by AI
How many people will be included in this clinical trial at most?
"The sponsor, Astellas Pharma Global Development, Inc., needs to recruit 116 eligible patients in order to carry out the study. The trial will take place at Mass General / North Shore Cancer in Boston, Massachusetts and UCLA Medical Center in Santa Monica, California amongst other sites."
Answered by AI
In how many countries is this clinical trial taking place?
"4 hospitals are currently running this study. They are in Boston, Santa Monica and Los Angeles but also other cities. If you want to make the process more convenient, enroll at the hospital closest to your home."
Answered by AI
To what extent has zolbetuximab been researched in the past?
"Zolbetuximab is being investigated in 2199 clinical trials, with 373 of those studies currently at Phase 3. The majority of these investigations are based out of Guangzhou, Guangdong; however, there are 94936 total locations running zolbetuximab trials."
Answered by AI
Is this research still looking for participants?
"The clinical trial, which is currently recruiting patients, was first posted on 6/29/2018. The last update to the posting was on 10/12/2022."
Answered by AI
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