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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate organ and bone marrow function (Hemoglobin >9.0 g/dL, Absolute neutrophil count ≥1,500/μL, Absolute lymphocyte count ≥600 and ≤2,500/μL, Platelet count ≥100,000/μL, Total bilirubin ≤1.5 × upper limit of normal, Alanine aminotransferase and aspartate aminotransferase ≤2.5 × ULN, Serum creatinine ≤1.5 × ULN or creatinine clearance >30 mL/min, Prothrombin time and activated partial thromboplastin time ≤1.5 × ULN)
WOCBP and sexually active fertile male patients with partners who are WOCBP must agree to use 2 highly effective methods of contraception throughout the course of the study and for 12 weeks after the last dose of study drug.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 56 months
Awards & highlights
Study Summary
This trial is assessing the safety and effectiveness of a new cancer drug, with the goal of finding the best dose and expanding to two new indications.
Who is the study for?
This trial is for adults with advanced solid tumors, including colorectal and non-small cell lung cancer, where standard treatments have failed or aren't suitable. Participants must be in relatively stable health with a life expectancy of at least 12 weeks and have adequate organ function. Women who can bear children and sexually active men must use effective contraception.Check my eligibility
What is being tested?
The study is testing EU101's safety and dosage limits in Phase 1, then its effectiveness against specific cancers in Phase 2. It involves gradually increasing doses to find the highest dose that doesn't cause unacceptable side effects (MTD) and deciding on the best dose for further studies (RP2D).See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include typical reactions to new cancer drugs such as fatigue, nausea, immune-related issues due to antibody treatment like inflammation or allergic reactions, blood count changes affecting immunity or clotting, liver or kidney function alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood tests show normal organ function and I don't have anemia or infections.
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I agree to use two effective birth control methods during and for 12 weeks after the study.
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My NSCLC lacks EGFR, ALK, ROS1 mutations, standard treatments failed or don't exist, and I've had ≤3 treatments for metastatic disease.
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I have colorectal cancer that has worsened after standard treatments and have had no more than 5 treatments for its advanced stage.
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I can take care of myself and am up and about more than half of my waking hours.
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My advanced cancer has no standard treatment options left or they were not effective.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 56 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 56 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1: Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Phase 1: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)
Phase 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
+4 moreSecondary outcome measures
Phase 1 and 2: Apparent Oral Clearance of (CL/F) of EU101
Phase 1 and 2: Apparent Volume of Distribution (Vd/F) of EU101
Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of EU101
+18 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: EU101: Dose Expansion Cohort 2Experimental Treatment1 Intervention
Participants with NSCLC will receive EU101 intravenously once every 3 weeks (3 weeks = 1 cycle) with a determined recommended phase 2 dose until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first.
Group II: EU101: Dose Expansion Cohort 1Experimental Treatment1 Intervention
Participants with CRC will receive EU101 intravenously once every 3 weeks (3 weeks = 1 cycle) with a determined recommended phase 2 dose until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first.
Group III: EU101: Dose Escalation CohortExperimental Treatment1 Intervention
Participants with advanced solid tumors will receive EU101 intravenously once every 3 weeks (3 weeks = 1 cycle) with escalating doses starting from 0.05 milligrams per kilogram (mg/kg) to 10 mg/kg until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first.
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Who is running the clinical trial?
EutilexLead Sponsor
3 Previous Clinical Trials
99 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have previously been treated with an anti-CD137 agent.My doctor thinks I shouldn't join the study.My blood tests show normal organ function and I don't have anemia or infections.I have had noninfectious hepatitis in the past.I am HIV positive.I do not have an active, uncontrolled infection or needed IV antibiotics recently.I agree to use two effective birth control methods during and for 12 weeks after the study.I have a brain tumor or cancer that has spread to my brain, but it's stable and I'm not on constant steroids.My NSCLC lacks EGFR, ALK, ROS1 mutations, standard treatments failed or don't exist, and I've had ≤3 treatments for metastatic disease.I have colorectal cancer that has worsened after standard treatments and have had no more than 5 treatments for its advanced stage.I can take care of myself and am up and about more than half of my waking hours.My advanced cancer has no standard treatment options left or they were not effective.You are expected to live for at least 12 more weeks.I have not taken steroids or immunosuppressants 1 week before starting EU101.I have or had lung disease, severe allergies, asthma, or inflammation of the lungs needing steroids.Women who could become pregnant must have a negative pregnancy test within the week before starting the study drug.I have been diagnosed with a second type of cancer.You are allergic to EU101 or any of the things it is made of.I haven't had major surgery or am fully recovered if it was within the last 3 weeks.I have an active hepatitis B or C infection.I have received an organ or tissue transplant from another person.I have a serious heart condition.I am not pregnant, breastfeeding, or planning to conceive and agree to use contraception.You must have at least one tumor that can be measured according to specific guidelines.I have had a severe allergic reaction to cancer treatment that needed steroids.
Research Study Groups:
This trial has the following groups:- Group 1: EU101: Dose Escalation Cohort
- Group 2: EU101: Dose Expansion Cohort 1
- Group 3: EU101: Dose Expansion Cohort 2
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 apex of patient participation in this experiment?
"Affirmative. According to clinicaltrials.gov, this trial was initially posted on May 31st 2021 and has since been actively recruiting participants at two sites with a requirement of 110 individuals in total."
Answered by AI
Are there currently any vacancies for participants in this research endeavor?
"The data posted on clinicaltrials.gov indicates that the recruitment process for this medical trial is still ongoing. It was initially advertised on May 31st 2021 and has since been updated as of July 12th 2022."
Answered by AI
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