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EU101 for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Eutilex

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)

Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2

Must not have

Received prior therapy with any anti-CD137 monoclonal antibody (mAb) or agent

History of any noninfectious hepatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 56 months

Awards & highlights

No Placebo-Only Group

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.

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).

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 below

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My blood tests show normal organ function and I don't have anemia or infections.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have previously been treated with an anti-CD137 agent.

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I have had noninfectious hepatitis in the past.

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I am HIV positive.

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I do not have an active, uncontrolled infection or needed IV antibiotics recently.

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I have not taken steroids or immunosuppressants 1 week before starting EU101.

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I have or had lung disease, severe allergies, asthma, or inflammation of the lungs needing steroids.

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I have been diagnosed with a second type of cancer.

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I haven't had major surgery or am fully recovered if it was within the last 3 weeks.

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I have an active hepatitis B or C infection.

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I have received an organ or tissue transplant from another person.

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I have a serious heart condition.

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I am not pregnant, breastfeeding, or planning to conceive and agree to use contraception.

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I have had a severe allergic reaction to cancer treatment that needed steroids.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 56 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

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

Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examination

+2 more

Secondary study objectives

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

+12 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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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