Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

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.

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.

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.

EU101 will be administered via intravenous infusion.

EU101

Seoyoun Kim, MPH

Anthony Olszanski, MD

Igor Astsaturov, MD

Efrat Dotan, MD

Angela Jain, MD

Jessica Bauman, MD

Daniel Geynisman, MD

Elizabeth Pilmack, MD

Joseph Bodor, MD

Anshu Giri, MD

Matthew Zibelman, MD

Minal Barve, MD

Jairo Olivares, MD

James Strauss, MD

Ntombizodwa Sayi, MD

Leah Plato, MD

Jennifer Ashun, MD

Douglas Orr, MD

Reva Schnieder, MD

Tak Yun, MD, PhD

Won-Young Choi, MD, PhD

Myung-Ju Ahn, MD, PhD

Jong-Mu Sun, MD, PhD

Jin-Seok Ahn, MD, PhD

Hyun-Ae Jung, MD, PhD

Se-Hoon Lee, MD, PhD

Ji-Yun Lee, MD, PhD

Seh-Hoon Park, MD, PhD

Tae Won Kim, MD, PhD

Jae-Ho Jeong, MD, PhD

Sang-We Kim, MD, PhD

Jeong-Eun Kim, MD, PhD

Hyung-Don Kim, MD, PhD

Dae-Ho Lee, MD, PhD

Se-Young Seo, MD, PhD

Shin-Kyo Yoon, MD, PhD

Yong-Sang Hong, MD, PhD

Hye Ryun Kim, MD

Min Hee Hong, MD

Chang Gon Kim, MD

Seung-Hoon Beom, MD

SANG JOON SHIN, MD

Min Hwan Kim, MD

Gun Min Kim, MD

Han Sang Kim, MD

Choong-kun Lee, MD

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).

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

Laboratory assessments include hematology, serum chemistry, other blood tests, coagulation, and urine analysis. Number of participants with clinically significant abnormalities will be reported.

Vital signs will include body temperature, pulse rate, and systolic and diastolic blood pressure measurements. Number of participants with clinically significant abnormalities will be reported.

Physical examination will include head, eyes, ears, nose and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems. Number of participants with clinically significant abnormalities will be reported.

ECG parameters included heart rhythm, pulse rate intervals, QRS, QT intervals, RR intervals and corrected QT(QTc) intervals. Number of participants with clinically significant abnormalities will be reported.

Objective response rate (ORR), defined as the percentage of participants with a best overall response (BOR) of either a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors by investigators.

Objective response rate (ORR), defined as the percentage of participants with a BOR of either a complete response (CR) or partial response (PR), per RECIST version 1.1 for solid tumors by investigators.

DCR will be defined similarly to ORR but also including stable disease (SD) in the categorization of response (i.e, RECIST response of either CR, PR, or SD).

DCB will be defined similarly to DCR but additionally specifying that the disease control be achieved for at least 12 weeks consecutive (i.e, RECIST response of CR, PR or SD for greater than or equal to \[\>=\] 12 weeks consecutive).

Cmax is defined as maximum observed serum concentration.

Ctrough is steady-state pre-dose concentration.

Tmax is defined as time to reach maximum observed serum concentration.

AUC0-24 is defined as the area under the serum concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24).

AUC0-last is defined as area under the serum concentration time-curve from time zero to the time of last measured concentration.

AUCinf is defined as area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf).

T1/2 is defined as plasma decay half-life is the time measured for the serum concentration to decrease by one half.

Vd/F is defined as volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug.

Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.

MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time.

CLr is defined as renal clearance is the volume of plasma completely cleared of EU101 by the kidneys per unit time.

The immunogenic potential of EU101 will be assessed by summarizing the number of participants who develop detectable antidrug antibody (ADAs).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors	NCT04903873	Solid Tumor Renal Cell Canc... Non-Small Cell ... Renal Cell Carc... Prostate Cancer	EU101	18 Years -	Eutilex
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors	NCT04903873	Solid Tumor Renal Cell Canc... Non-Small Cell ... Renal Cell Carc... Prostate Cancer	EU101	18 Years -	Eutilex

Spots Global Cancer Trial Database for eu101

Every month we try and update this database with for eu101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for eu101

Every month we try and update this database with for eu101 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for eu101 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.