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

NCT04903873 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EU-CTS101-I-01
• Study Type: interventional
• Target: 110
• Locations: 2 countries
• Sites: 6

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

Keywords

Renal Cell Carcinoma; Prostate Cancer; Dose Escalation; Maximum tolerated dose

Outcome Measures

Primary Outcomes (7)

• Phase 1: Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation

  Baseline up to 30 months

• Phase 1: Number of Participants With Dose Limiting Toxicity (DLT)

  At the end of Cycle 1 (Each cycle is of 21 Days)

• Phase 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters

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

  Baseline up to 24 months

• Phase 1: Number of Participants With Clinically Significant Abnormalities in Vital Signs

  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.

  Baseline up to 24 months

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

  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.

  Baseline up to 24 months

• Phase 1: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)

  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.

  Baseline up to 24 months

• Phase 2: Objective Response Rate (ORR)

  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.

  Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)

Secondary Outcomes (21)

• Phase 1: Objective Response Rate (ORR)

  Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)

• Phase 1 and 2: Duration of Response (DOR)

  Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)

• Phase 1 and 2: Disease Control Rate (DCR)

  Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)

• Phase 1 and 2: Time to Response (TTR)

  Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)

• Phase 1 and 2: Time to Progression (TTP)

  Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 56 months)

Study Arms (3)

EU101: Dose Escalation Cohort

EXPERIMENTAL

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.

Drug: EU101

EU101: Dose Expansion Cohort 1

EXPERIMENTAL

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.

Drug: EU101

EU101: Dose Expansion Cohort 2

EXPERIMENTAL

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.

Drug: EU101

Interventions

EU101 DRUG

EU101 will be administered via intravenous infusion.

EU101: Dose Escalation Cohort; EU101: Dose Expansion Cohort 1; EU101: Dose Expansion Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eutilex: lead

Study Sites (6)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

RECRUITING

Mary Crowley Center

Dallas, Texas, 75230, United States

RECRUITING

National Cancer Center

Ilsan, South Korea

NOT YET RECRUITING

Samsung Seoul Hospital

Seoul, South Korea

RECRUITING

Seoul Asan

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Renal Cell; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Genital Diseases; Prostatic Diseases

Central Study Contacts

Seoyoun Kim, MPH

CONTACT

82-10-4227-0925; s.kim@eutilex.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 27, 2021
• Study Start: May 31, 2021
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); KR (4)