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Anti-metabolites
Zolbetuximab + Chemotherapy for Gastric Cancer (Spotlight Trial)
Phase 3
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
Male subject must agree not to donate sperm starting at screening and throughout the study period, and for 6 months after the final study drug administration
Subject has a HER2-Negative tumor as determined by local or central testing on a gastric or GEJ tumor specimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 23 months
Awards & highlights
Spotlight Trial Summary
This trial is for patients with Claudin 18.2 positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
Who is the study for?
Adults with advanced unresectable or metastatic gastric/GEJ cancer that's HER2-negative and expresses Claudin 18.2 proteins can join this trial. They must have an ECOG performance status of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. Participants should not be pregnant, breastfeeding, or planning to donate eggs/sperm; contraception is required. Those who've had certain treatments for these cancers within specific timeframes before the study starts cannot participate.Check my eligibility
What is being tested?
The trial tests zolbetuximab (IMAB362), which targets Claudin 18.2 on cancer cells, combined with mFOLFOX6 chemotherapy versus a placebo plus mFOLFOX6 in patients with specific gastric cancers. The goal is to see if zolbetuximab helps extend life by preventing cancer progression.See study design
What are the potential side effects?
Zolbetuximab may cause allergic reactions due to its nature as a monoclonal antibody and could lead to immune-related side effects similar to other antibodies used in cancer treatment such as inflammation of organs and infusion reactions. Chemotherapy components like fluorouracil can cause nausea, low blood counts leading to increased infection risk, mouth sores, and neuropathy.
Spotlight Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree not to donate sperm from the start of the study until 6 months after the last dose of the study drug.
Select...
My tumor is HER2-negative, confirmed by tests on a stomach or GEJ sample.
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...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have been diagnosed with stomach or gastroesophageal junction cancer.
Select...
I am not pregnant, confirmed by a test.
Spotlight Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 23 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 23 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression Free Survival (PFS)
Secondary outcome measures
Duration Of Response (DOR)
HRQoL measured by the EuroQOL Five Dimensions Questionnaire 5L (EQ-5D-5L) questionnaire
HRQoL measured by the Global Pain (GP) questionnaire
+12 moreSpotlight Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm A (zolbetuximab plus mFOLFOX6)Experimental Treatment4 Interventions
Participants will receive a loading dose of zolbetuximab at Cycle 1 Day 1 followed by a lower dose in subsequent cycles every 3 weeks. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Group II: Arm B (Placebo plus mFOLFOX6)Placebo Group4 Interventions
Participants will receive placebo starting at Cycle 1 Day 1 and every 3 weeks thereafter. Additionally, participants will receive up to 12 treatments of mFOLFOX6 (or components of mFOLFOX6 if some components are discontinued due to toxicity) over 4 or more cycles (each cycle is approximately 42 days) in which mFOLFOX6 is administered on Days 1, 15 and 29. After 12 mFOLFOX6 treatments, participants may continue to receive fluorouracil (5-FU) and folinic acid at the investigator's discretion until the subject meets study treatment discontinuation criteria.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
oxaliplatin
2002
Completed Phase 3
~6370
fluorouracil
1994
Completed Phase 3
~8440
folinic acid
2009
Completed Phase 3
~580
zolbetuximab
2019
Completed Phase 2
~270
Find a Location
Who is running the clinical trial?
Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
120,496 Total Patients Enrolled
Global Medical LeadStudy DirectorAstellas Pharma Global Development, Inc.
4 Previous Clinical Trials
259 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tested positive for HIV or active hepatitis B or C.I have been treated for an autoimmune disease in the last 3 months.I have had chemotherapy for advanced stomach or GEJ cancer that cannot be surgically removed.I had major surgery less than 2 weeks ago and haven't fully recovered.I have had severe allergic reactions to certain cancer drugs or their ingredients.I do not have any health conditions that would make it unsafe for me to join the study.I agree not to breastfeed during and for 6 months after the study.I will not donate eggs during and up to 9 months after my last oxaliplatin dose, and 6 months after other study drugs.I have an infection needing treatment that hasn't cleared in the last week.I agree not to donate sperm from the start of the study until 6 months after the last dose of the study drug.My cancer can be measured by scans taken less than 28 days ago.My tumor is HER2-negative, confirmed by tests on a stomach or GEJ sample.I have severe blockage in my stomach causing vomiting.I do not have significant stomach bleeding or untreated ulcers.I agree to use contraception for 6 months after my last treatment.I will not have unprotected sex if my partner is pregnant or breastfeeding during the study and for 6 months after.My advanced cancer is confirmed by scans and cannot be surgically removed.My tumor shows high CLDN18.2 expression.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with stomach or gastroesophageal junction cancer.I have a known deficiency in the enzyme dihydropyrimidine dehydrogenase.I am not pregnant, confirmed by a test.I have mild nerve damage in my hands or feet, but can still feel normally.I have a serious heart condition.I had radiotherapy for stomach cancer less than 14 days ago and still have side effects.I have not taken immunosuppressive drugs or steroids in the last 14 days.My cancer has spread to my brain or spinal cord.I had major surgery less than 28 days ago.I need treatment for another type of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (zolbetuximab plus mFOLFOX6)
- Group 2: Arm B (Placebo plus mFOLFOX6)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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 are zolbetuximab's benefits in prescription form?
"Zolbetuximab is frequently used to treat advanced esophageal cancers. Additionally, it is an accepted course of treatment for stage iii colon cancer, advanced gastric cancer, and other disorders like folate deficiency."
Answered by AI
Are there any slots remaining for participants in this experiment?
"No, this study is not recruiting patients as of right now. The trial was first posted on June 21st, 2018 and was last updated on October 24th, 2022. There are, however, 1346 other trials that are presently looking for volunteers."
Answered by AI
Are there zolbetuximab trials ongoing in other hospitals?
"At this moment, 565 different clinical trials are ongoing that are researching zolbetuximab. Out of those 565 trials, 195 are currently in Phase 3. Most of the trials taking place are in Woolloongabba, Queensland, but there are 26201 total locations running trials for zolbetuximab."
Answered by AI
Does zolbetuximab put patients at risk for developing complications?
"Zolbetuximab is classified as a Phase 3 drug, so it has received a safety score of 3 from our analysts. This is because there is both efficacy and safety data available from previous clinical trials."
Answered by AI
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