RECRUITING

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

Conditions

Solid Tumor Renal Cell Cancer Metastatic Non-Small Cell Lung Cancer Renal Cell Carcinoma Prostate Cancer Dose Escalation Maximum tolerated dose

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

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

Quick Facts

Study Start:2021-05-31

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04903873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed because of disease progression or unacceptable toxicities. Also includes patients who cannot be treated with standard therapy because of underlying/existing medical condition. * Cohort 1 (colorectal cancer): a) CRC (including microsatellite instability-high \[MSI-H\] and microsatellite-stable \[MSS\]) regardless of RAS mutation. b) Disease progression within 3 months after last administration of approved standard therapies. c) Prior cytotoxic chemotherapy for metastatic disease include all the following agents: fluoropyrimidine, oxaliplatin, and irinotecan * Adjuvant chemotherapy-based treatments count as prior therapy, as long as relapse had occurred within 6 months of completion of such therapies, prior anti-epidermal growth factor receptor (EGFR) therapy (cetuximab, panitumumab), anti-angiogenic therapy (bevacizumab, aflibercept, ramucirumab), regorafenib, and TAS-102 are allowed. d) No more than 5 prior therapies for metastatic disease. For participants who had disease recurrence within 6 months of completing adjuvant chemotherapy, the adjuvant regimen can be considered as 1 chemotherapy regimen for metastatic disease * Cohort 2 (NSCLC): a) NSCLC without known EGFR, anaplastic lymphoma kinase (ALK), and ROS1 genomic tumor aberrations. b) No standard therapy exists or standard therapy has failed. c) No more than 3 prior therapies for metastatic disease * Phase 2: At least 1 measurable lesion per RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 * 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) * Life expectancy of at least 12 weeks * Voluntarily provided a written consent to participate in the study * Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days before study drug administration * 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.	* Primary central nervous system (CNS) tumor (Phase 1), CNS metastasis, and/or carcinomatous meningitis. Participants with prior brain metastases treated at least 4 weeks before the first dose of EU101 that are clinically stable and do not require chronic corticosteroid treatment are allowed. Untreated but asymptomatic and clinically stable brain metastases per investigator's discretion are allowed * Received prior therapy with any anti-CD137 monoclonal antibody (mAb) or agent * Major surgery requiring general anesthesia within 3 weeks before first dose of EU101 or still recovering from prior surgery * Active infection that is not controlled or requires intravenous antibiotics in the last 2 weeks * History of allogeneic tissue or organ transplant * Active hepatitis B virus or hepatitis C virus infection * History of any noninfectious hepatitis * Human immunodeficiency virus (HIV) infection * Received or receiving systemic corticosteroid therapy or any other form of systemic immunosuppressive medicaion 1 week before first dose of EU101 * Known severe (≥Grade 3) hypersensitivity reactions to antibody, or severe reaction to immuno-oncology agents requiring treatment with steroids * Konwn or suspected hypersensitivity to EU101 or any component of its formulation * Current or history of interstitial lung disease, anaphylaxis, uncontrolled asthma, or pneumonitis that has required systemic corticosteroids * Patients with second primary cancer * Clinically significant concurrent cardiovascular disease * Pregnant women, breasfeeding women, WOCBP, or men with partners who are WOCBP who do not agree to use adequate contraceptive measures * Determined as unable to participate in the study per investigator's judgment

Inclusion Criteria

Exclusion Criteria

* Histologically or cytologically confirmed diagnosis of metastatic or locally advanced solid tumors for which no standard therapy exists or standard therapy has failed because of disease progression or unacceptable toxicities. Also includes patients who cannot be treated with standard therapy because of underlying/existing medical condition.
* Cohort 1 (colorectal cancer): a) CRC (including microsatellite instability-high \[MSI-H\] and microsatellite-stable \[MSS\]) regardless of RAS mutation. b) Disease progression within 3 months after last administration of approved standard therapies. c) Prior cytotoxic chemotherapy for metastatic disease include all the following agents: fluoropyrimidine, oxaliplatin, and irinotecan
* Adjuvant chemotherapy-based treatments count as prior therapy, as long as relapse had occurred within 6 months of completion of such therapies, prior anti-epidermal growth factor receptor (EGFR) therapy (cetuximab, panitumumab), anti-angiogenic therapy (bevacizumab, aflibercept, ramucirumab), regorafenib, and TAS-102 are allowed. d) No more than 5 prior therapies for metastatic disease. For participants who had disease recurrence within 6 months of completing adjuvant chemotherapy, the adjuvant regimen can be considered as 1 chemotherapy regimen for metastatic disease
* Cohort 2 (NSCLC): a) NSCLC without known EGFR, anaplastic lymphoma kinase (ALK), and ROS1 genomic tumor aberrations. b) No standard therapy exists or standard therapy has failed. c) No more than 3 prior therapies for metastatic disease
* Phase 2: At least 1 measurable lesion per RECIST version 1.1
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2
* 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)
* Life expectancy of at least 12 weeks
* Voluntarily provided a written consent to participate in the study
* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days before study drug administration
* 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.

* Primary central nervous system (CNS) tumor (Phase 1), CNS metastasis, and/or carcinomatous meningitis. Participants with prior brain metastases treated at least 4 weeks before the first dose of EU101 that are clinically stable and do not require chronic corticosteroid treatment are allowed. Untreated but asymptomatic and clinically stable brain metastases per investigator's discretion are allowed
* Received prior therapy with any anti-CD137 monoclonal antibody (mAb) or agent
* Major surgery requiring general anesthesia within 3 weeks before first dose of EU101 or still recovering from prior surgery
* Active infection that is not controlled or requires intravenous antibiotics in the last 2 weeks
* History of allogeneic tissue or organ transplant
* Active hepatitis B virus or hepatitis C virus infection
* History of any noninfectious hepatitis
* Human immunodeficiency virus (HIV) infection
* Received or receiving systemic corticosteroid therapy or any other form of systemic immunosuppressive medicaion 1 week before first dose of EU101
* Known severe (≥Grade 3) hypersensitivity reactions to antibody, or severe reaction to immuno-oncology agents requiring treatment with steroids
* Konwn or suspected hypersensitivity to EU101 or any component of its formulation
* Current or history of interstitial lung disease, anaphylaxis, uncontrolled asthma, or pneumonitis that has required systemic corticosteroids
* Patients with second primary cancer
* Clinically significant concurrent cardiovascular disease
* Pregnant women, breasfeeding women, WOCBP, or men with partners who are WOCBP who do not agree to use adequate contraceptive measures
* Determined as unable to participate in the study per investigator's judgment

Contacts and Locations

Study Contact

Seoyoun Kim, MPH

CONTACT

82-10-4227-0925

s.kim@eutilex.com

Study Locations (Sites)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

United States

Mary Crowley Center

Dallas, Texas, 75230

United States

Collaborators and Investigators

Sponsor: Eutilex

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-31

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-05-31

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Renal Cell Carcinoma
Prostate Cancer
Dose Escalation
Maximum tolerated dose

Additional Relevant MeSH Terms

Solid Tumor
Renal Cell Cancer Metastatic
Non-Small Cell Lung Cancer
Renal Cell Carcinoma
Prostate Cancer