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Cancer Vaccine
EO-3021 for Gastrointestinal Cancer
Phase 1
Recruiting
Research Sponsored by Elevation Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through safety follow-up (28 days after the last dose)
Awards & highlights
Study Summary
This trial studies a new cancer drug in adults with solid tumors likely to express a specific protein.
Who is the study for?
Adults with advanced or metastatic solid tumors likely to express CLDN18.2, such as stomach, pancreatic, and esophageal cancers. Participants must be over 18, have a good performance status (able to carry out daily activities), adequate organ function, and agree to use birth control. They should have tried standard treatments without success or cannot tolerate them.Check my eligibility
What is being tested?
The trial is testing EO-3021 in patients with certain types of cancer that are expected to show the presence of a protein called CLDN18.2. It's an early-phase study assessing how safe the drug is and how it affects these tumors.See study design
What are the potential side effects?
Specific side effects for EO-3021 aren't listed but may include typical reactions seen with antibody drugs like infusion-related discomfort, allergic reactions, fatigue, nausea, and potential impacts on blood counts leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through safety follow-up (28 days after the last dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of informed consent, for approximately 12 months (or earlier if the participant discontinues from the study), and through safety follow-up (28 days after the last dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of patients with clinically significant changes in laboratory tests
Number of patients with clinically significant changes to vital signs
Number of patients with serious adverse events
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part B ExpansionExperimental Treatment1 Intervention
Patients with select advanced unresectable or metastatic solid tumors will receive EO-3021 IV infusion every 3 weeks to confirm the RP2D.
Group II: Part A: EscalationExperimental Treatment1 Intervention
Adult patients with select advanced unresectable or metastatic solid tumors likely to express CLDN18.2 will receive EO-3021 IV infusion at various doses every 3 weeks to determine MTD/RP2D(s).
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Who is running the clinical trial?
Elevation OncologyLead Sponsor
3 Previous Clinical Trials
250 Total Patients Enrolled
Valerie Jansen, MD, PhDStudy DirectorElevation Oncology, Inc.
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have had a stem cell or organ transplant and am on ongoing immunosuppressive therapy.I have been treated with specific antibody drugs for my cancer.My cancer is in an advanced stage and likely to express a specific protein.I have brain metastases that are causing symptoms or have not been treated.I do not have serious heart conditions like recent heart attacks or unstable heart rhythms.I have had lung inflammation not caused by an infection.My organs are working well.I am fully active or restricted in physically strenuous activity but can do light work.My condition worsened after standard treatment, or I can't tolerate it, or there's no treatment available.I have an eye condition diagnosed by an eye doctor.I haven't had treatment for another cancer in the last 3 years, except for early-stage cancers deemed unlikely to recur.I have moderate to severe numbness, tingling, or pain in my hands or feet.I do not have any serious illnesses or active infections.
Research Study Groups:
This trial has the following groups:- Group 1: Part A: Escalation
- Group 2: Part B Expansion
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.
Has Part A: Escalation been sanctioned by the FDA?
"Our team at Power gave Part A: Escalation a score of 1 due to the limited clinical data that supports its safety and efficacy, as this is just a Phase 1 trial."
Answered by AI
What is the magnitude of participation in this experiment?
"Affirmative. The information on clinicaltrials.gov points to this medical trial currently recruiting participants, which was first posted on August 10th 2023 and last updated on the 16th of the same month. 120 individuals are required from two distinct sites for enrollment in this experiment."
Answered by AI
Is this experiment still enrolling participants?
"Accurate. Clinicaltrials.gov has registered that this research is actively searching for participants, having first been posted on August 10th 2023 and last updated on the 16th of August of the same year. It requires 120 volunteers to be recruited from 2 trial sites."
Answered by AI
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