Lung Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT04903873

Recruitment Status:

Recruiting

Sponsor:

Eutilex

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There are 2 Locations for this study

See Locations Near You

Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States More Info
Anthony Olszanski, MD
Contact
Igor Astsaturov, MD
Sub-Investigator
Efrat Dotan, MD
Sub-Investigator
Angela Jain, MD
Sub-Investigator
Jessica Bauman, MD
Sub-Investigator
Daniel Geynisman, MD
Sub-Investigator
Elizabeth Pilmack, MD
Sub-Investigator
Joseph Bodor, MD
Sub-Investigator
Anshu Giri, MD
Sub-Investigator
Matthew Zibelman, MD
Sub-Investigator
Mary Crowley Center
Dallas Texas, 75230, United States More Info
Minal Barve, MD
Contact
Jairo Olivares, MD
Sub-Investigator
James Strauss, MD
Sub-Investigator
Ntombizodwa Sayi, MD
Sub-Investigator
Leah Plato, MD
Sub-Investigator
Jennifer Ashun, MD
Sub-Investigator
Douglas Orr, MD
Sub-Investigator
Reva Schnieder, MD
Sub-Investigator
National Cancer Center
Ilsan , , Korea, Republic of More Info
Tak Yun, MD, PhD
Contact
Tak Yun, MD, PhD
Sub-Investigator
Won-Young Choi, MD, PhD
Sub-Investigator
Samsung Seoul Hospital
Seoul , , Korea, Republic of More Info
Myung-Ju Ahn, MD, PhD
Contact
Jong-Mu Sun, MD, PhD
Sub-Investigator
Jin-Seok Ahn, MD, PhD
Sub-Investigator
Hyun-Ae Jung, MD, PhD
Sub-Investigator
Se-Hoon Lee, MD, PhD
Sub-Investigator
Ji-Yun Lee, MD, PhD
Sub-Investigator
Seh-Hoon Park, MD, PhD
Sub-Investigator
Seoul Asan
Seoul , , Korea, Republic of More Info
Tae Won Kim, MD, PhD
Contact
Jae-Ho Jeong, MD, PhD
Sub-Investigator
Sang-We Kim, MD, PhD
Sub-Investigator
Jeong-Eun Kim, MD, PhD
Sub-Investigator
Hyung-Don Kim, MD, PhD
Sub-Investigator
Dae-Ho Lee, MD, PhD
Sub-Investigator
Se-Young Seo, MD, PhD
Sub-Investigator
Shin-Kyo Yoon, MD, PhD
Sub-Investigator
Yong-Sang Hong, MD, PhD
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

110

Study ID:

NCT04903873

Recruitment Status:

Recruiting

Sponsor:


Eutilex

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