RecruitingPhase 1Phase 2NCT04903873

A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors

An Open-Label, Phase 1/2 Study to Evaluate Safety, Efficacy, and Pharmacokinetics of EU101, an Agonistic Anti-CD137 (4-1BB) Monoclonal Antibody in Patients With Advanced Solid Tumors


Sponsor

Eutilex

Enrollment

110 participants

Start Date

May 31, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

Phase 1 (Dose Escalation) of this study will assess the safety, tolerability, dose-limiting toxicity (DLT), and will determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of EU101 in participants with advanced solid tumors. Phase 2 (Dose Expansion) of the study will assess the antitumor effect of EU101 in two indications including colorectal cancer (CRC) and non-small cell lung cancer (NSCLC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug combination in people with advanced solid tumors, including colorectal cancer, gastric cancer, and other tumors that no longer respond to standard treatments. It looks at safety, dosing, and early signs of effectiveness. **You may be eligible if...** - You have a confirmed advanced or metastatic solid tumor and have run out of standard treatment options - For colorectal cancer: you must have progressed on all standard therapies including fluorouracil, oxaliplatin, and irinotecan - For gastric or other cancers: specific criteria apply based on prior treatment history - You are in good general health (ECOG 0 or 1) with adequate organ function **You may NOT be eligible if...** - Your cancer is localized and potentially curable by surgery - You have serious ongoing infections or autoimmune conditions - You have had more than 5 prior treatments for metastatic disease - You have active brain metastases requiring treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEU101

EU101 will be administered via intravenous infusion.


Locations(6)

Samsung Seoul Hospital

Seoul, South Korea

Seoul Asan

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

National Cancer Center

Ilsan, South Korea

Mary Crowley Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04903873


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