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

NCT ID: NCT04903873

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-31
• Study Completion Date: 2025-12-31

Brief 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).

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EU101: Dose Escalation Cohort

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.

Group Type: EXPERIMENTAL

EU101

Intervention Type: DRUG

EU101 will be administered via intravenous infusion.

EU101: Dose Expansion Cohort 1

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 Type: EXPERIMENTAL

EU101

Intervention Type: DRUG

EU101 will be administered via intravenous infusion.

EU101: Dose Expansion Cohort 2

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 Type: EXPERIMENTAL

EU101

Intervention Type: DRUG

EU101 will be administered via intravenous infusion.

Interventions

EU101

EU101 will be administered via intravenous infusion.

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eutilex

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Site Status: RECRUITING

Mary Crowley Center

Dallas, Texas, United States

Site Status: RECRUITING

National Cancer Center

Ilsan, , South Korea

Site Status: NOT_YET_RECRUITING

Samsung Seoul Hospital

Seoul, , South Korea

Site Status: RECRUITING

Seoul Asan

Seoul, , South Korea

Site Status: RECRUITING

Severance Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

United States; South Korea

Central Contacts

Seoyoun Kim, MPH

Role: CONTACT

s.kim@eutilex.com

82-10-4227-0925

Facility Contacts

Anthony Olszanski, MD

Role: primary

Minal Barve, MD

Role: primary

Tak Yun, MD, PhD

Role: primary

Myung-Ju Ahn, MD, PhD

Role: primary

Tae Won Kim, MD, PhD

Role: primary

Hye Ryun Kim, MD

Role: primary

Other Identifiers

EU-CTS101-I-01

Identifier Type: -

Identifier Source: org_study_id