Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Eutilex

Code:

NCT04903873

Conditions

Solid Tumor

Renal Cell Cancer Metastatic

Non-Small Cell Lung Cancer

Renal Cell Carcinoma

Prostate Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

EU101

Study Details

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 ID

NCT04903873

Start date

May 31, 2021

Status verified date

Mar, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key 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.

Key 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

Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Enrollment

110 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

experimental: 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.

experimental: 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.

Interventions

EU101

EU101 will be administered via intravenous infusion.

Primary outcome measure

  • Phase 1: Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation [ Time Frame: Baseline up to 30 months ]
  • Phase 1: Number of Participants With Dose Limiting Toxicity (DLT) [ Time Frame: At the end of Cycle 1 (Each cycle is of 21 Days) ]
  • Phase 1: Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters [ Time Frame: Baseline up to 24 months ]
  • Phase 1: Number of Participants With Clinically Significant Abnormalities in Vital Signs [ Time Frame: Baseline up to 24 months ]
  • Phase 1: Number of Participants With Clinically Significant Abnormalities in Physical Examination [ Time Frame: Baseline up to 24 months ]
  • Phase 1: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) [ Time Frame: Baseline up to 24 months ]
  • Phase 2: Objective Response Rate (ORR) [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

Seoyoun Kim, MPH

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

Locations

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Mary Crowley Center

Recruiting

Dallas, Texas, United States, 75230

More Information

Sponsor

Eutilex

Last update posted

Mar 15, 2024

Last verified

Mar, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Eutilex on 2024-03-15.