Solid TumorPhase 1NCT05798026
A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU103 in Advanced or Metastatic Solid Tumors That Have Failed Standard Therapy
A Phase 1 study testing EU103 in people with Solid Tumor, run by Eutilex at 3 sites in South Korea.
Trial summary
Phase 1 (dose escalation) of this study will evaluate: The safety and tolerability of EU103 treatment are evaluated for patients with advanced or metastatic solid tumors who have failed standard therapy to determine the maximum tolerated dose and recommended Phase 2 dose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- EU103
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 8 Aug 2023to 31 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males or females aged 18 years (or 19 years according to local regulatory requirements) or older at the time of obtaining written consent
- Patients with histologically or cytologically confirmed unresectable advanced or metastatic solid tumors who have failed locally known standard therapies or are unable to apply any more standard therapies.
- Patients with at least 1 measurable or non-measurable lesion per RECIST v1.1
- Patients with an estimated survival of 3 months or longer, as determined by the investigator
- Patients with ECOG PS 0-2
- Patients with adequate bone marrow, liver, and renal functions at the time of screening
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- Absolute Neutrophil Count (ANC) ≥ 1,500 /μL
- Platelet ≥ 100,000 /μL
- Hemoglobin ≥ 9.0 g/dL (If the hemoglobin level of a patient is below 9.0 g/dL, he/she may be enrolled upon recovery to 9.0 g/dL or higher. However, blood transfusions performed in order to meet this criterion within 14 days before screening are not allowed.)
- AST and/or ALT ≤ 2.5x ULN (≤ 5 x ULN if liver metastases are present)
- Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if liver metastases are present)
- Serum creatinine ≤1.5 x ULN
- However, if serum creatinine is >1.5 x ULN, Creatinine clearance (CrCl) ≥ 60 mL/min is allowed for enrollment.
- PT (INR) ≤1.5 x ULN
- Those who provide or can provide newly obtained tumor biopsies (preferred) or archived tumor tissue specimens during the screening period.
- In patients recruited to the dose escalation phase for DLT evaluation, provision of tumor tissue specimens is preferred but not required.
- Patients included in cohort reinforcement must agree to provide a tumor tissue specimen during the screening period and to undergo an additional biopsy in cycle 1 (before the start of cycle 2).
- If possible, cycle 1 (before cycle 2) biopsies should be obtained from the same organ site as the biopsy provided at screening to avoid heterogeneity related to tumor or metastatic sites.
- The neoplastic lesion to be used for a newly acquired biopsy should not be a target lesion unless there are no other suitable lesions, in which case only central needle (non-excisional/non-incisional) biopsy should be performed. It is allowed.
- Specimens from metastatic bone lesions are generally not accepted unless they have a significant soft tissue component. The amount of tumor specimen should be sufficient to allow exploratory biomarker analysis, preferably in the form of formalin-fixed paraffin-embedded blocks or slides.
- For women of childbearing potential, the serum pregnancy test is negative
- Women of childbearing potential or men who do not plan for pregnancy during the study and for 6 months after the last dose of investigational product and who agree to maintain the following clinically appropriate methods of contraception during the period
- Hormonal contraceptive methods (such as subdermal implants, injections, oral contraceptives, etc.), intrauterine device (IUD) or Intra uterine system (IUS), sterilization surgery of the subject or the subject's partner (vasectomy, tubal ligation, etc.), double barrier methods (such as combined use of a cervical cap or a diaphragm with a male condom)
- Patients who have given their written consent to voluntarily participate in this study
Who cannot join
- Patients who have received prior anticancer therapy, monoclonal antibodies, chemotherapy, live vaccines, or other investigational products, or have a history of treatment with an investigational medical device within 4 weeks prior to the first dose of the investigational product
- Patients who have not recovered (to Grade 1 or better, or the baseline level per NCI-CTCAE v5.0) from the adverse events (excluding alopecia) caused by prior anticancer therapy based on the start date of the first dose of the investigational product
- Patients with a history of radiotherapy within 2 weeks prior to the investigational product administration Note. Subjects must have recovered from all radiation-related toxicities, not require corticosteroid use, and have no history of radiation pneumonitis. A 1-week recovery period is allowed for palliative radiotherapy (not more than 2 weeks of radiotherapy) for diseases other than the central nervous system (CNS) diseases.
- Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia, or past history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or evidence of clinically active ILD
- Patients with symptomatic ascites or pleural effusion Note. Enrollment is allowed if clinically stable after treatment for the condition (including thoracentesis or paracentesis for therapeutic purposes).
- Patients with uncontrolled tumor-related pain (Patients with symptomatic lesions that can be treated with palliative radiotherapy [e.g., bone metastases or metastases causing nerve impingement] can be enrolled after treatment prior to screening).
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- Patients with known symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease
- Patients who have had or currently have any of the following infections:
- Individuals with a history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) (However, patients with human immunodeficiency virus (HIV) who have no history of opportunistic infection and a CD4+ T cell (CD4+) count ≥350 cells/uL within 12 months prior to screening are allowed for enrollment)
- Patients with active hepatitis B (However, those who have negative HBV titer based on the determination of the study site within 14 days prior to screening, have received antiviral therapy for at least 14 days prior to screening and are willing to maintain it throughout the study period are eligible for enrollment.)
- Patients with active hepatitis C (However, if patients have completed antiviral treatment and their HCV viral load is negative based on the determination of the study site, they are eligible for enrollment.)
- Patients with active infection accompanied by uncontrolled severe chronic infection or requiring treatment
- Patients who have been diagnosed with a malignancy other than the indication in this study within 5 years prior to screening (However, patients who have been assessed as having complete response after treatment and have not relapsed within at least 3 years from the time of screening, or patients with non-melanoma skin cancer, in-situ disease, thyroid cancer, or borderline tumors are eligible for enrollment)
- Patients with severe cardiac diseases clinically significant as determined by the investigator
- Including but not limited to the following diseases: uncontrolled hypertension, congestive heart failure [NYHA Grade 2 or higher], ventricular arrhythmia, active ischemic heart disease, myocardial infarction within 1 year prior to screening, QTcF ≥ 450 ms (males) / ≥ 470 ms (females), or other cardiac diseases that, in the judgment of the investigator, preclude participation in this study.
- Patients who are expected to require major surgery requiring general anesthesia within 4 weeks prior to administration of the investigational product or during the study
- Patients who have received immunosuppressants within 2 weeks prior to the investigational product administration However, enrollment is allowed in the following cases: i) intranasal, inhaled, applied steroids or topical steroids; ii) prednisone less than 10 mg/day or equivalent dose of other corticosteroids; iii) steroids for prevention of hypersensitivity.
- Patients who have received drugs targeting V-set and immunoglobulin domain containing 4 (VSIG4)
- Patients with a history of hypersensitivity to the components of the investigational product or drugs in the same class (humanized/human monoclonal antibody treatments)
- Pregnant women, lactating women, or those who are planning to become pregnant during this study period
- Patients who are determined to be inappropriate for participation in this study as determined by the investigator
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Asan Medical Center
Seoul
Jae-Lyun Lee, MD, PhD
- Recruiting
Samsung Seoul Hospital
Seoul
Myung-Ju Ahn, MD, PhD
- Recruiting
Seoul National University Hospital
Seoul
Do-Youn Oh, MD, PhD
About this study
Official title: A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU103 in an Advanced or Metastatic Solid Tumors Who Have Failed Standard Therapy
Phase 1 (dose escalation) of this study will evaluate:
The safety and tolerability of EU103 treatment are evaluated for patients with advanced or metastatic solid tumors who have failed standard therapy to determine the maximum tolerated dose and recommended Phase 2 dose.
And preliminary efficacy (tumor response), The pharmacokinetic characteristics are evaluated, and changes are investigated.
- Conditions
- Solid Tumor
- Being tested
- EU103
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EU103Drug
EU103 will be administered via intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| EU103: Dose Escalation Cohort | Experimental | Participants with advanced solid tumors will receive EU103 intravenously once every 3 weeks (3 weeks = 1 cycle) with escalating doses starting from 1 milligrams per kilogram (mg/kg) for each cohort and increasing to 3, 6, 12 or 24 mg/kg until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first. Receives: Drug: EU103 |
| EU103: Dose Escalation Cohort 1 | Experimental | 1 mg/kg Receives: Drug: EU103 |
| EU103: Dose Escalation Cohort 2 | Experimental | 3 mg/kg Receives: Drug: EU103 |
| EU103: Dose Escalation Cohort 3 | Experimental | 6 mg/kg Receives: Drug: EU103 |
| EU103: Dose Escalation Cohort 4 | Experimental | 12 mg/kg Receives: Drug: EU103 |
| EU103: Dose Escalation Cohort 5 | Experimental | 24 mg/kg Receives: Drug: EU103 |
| Backfill cohort | Other | Additional subjects can be registered at doses confirmed to be safety Receives: Drug: EU103 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events
Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Measured: Baseline up to 30 months
Dose Limiting Toxicity (DLT)
Number of Participants With Dose Limiting Toxicity (DLT)
Measured: 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.
Measured: Time Frame: Baseline up to 24 months
Number of participants with clinically significant abnormalities
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.
Measured: Time Frame: 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.
Measured: Time Frame: Baseline up to 24 months
Phase 1:Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)Physical Examination
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.
Measured: Time Frame: Baseline up to 24 months
Phase 1:Production of anti-drug antibodies (ADAs)
The number of subjects, percentage, and Exact 95% confidence interval for subjects who are anti-drug antibody (ADA) positive at each measurement time point compared to before administration of investigational drugs are presented for each dose level.
Measured: Time Frame: Baseline up to 30 months
Secondary outcomes (7)
Phase 1:Objective response rate (ORR)
Proportion of subjects whose best overall response (BOR) is confirmed as complete response (CR) or partial response (PR)
Measured: 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:Duration of response (DoR)
Time from achievement of tumor response (CR or PR) to the time of confirmed progressive disease (PD)
Measured: 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:Disease control rate (DCR)
Proportion of subjects whose BOR is confirmed as CR, PR, or stable disease (SD: 6 weeks or longer)
Measured: 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:Time to response (TTR)
Time from the date of the investigational product administration to the time of confirmed objective response (CR or PR)
Measured: 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:Time to progression (TTP)
Time from the date of the investigational product administration to the time of PD
Measured: 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:Progression-free survival (PFS)
Time from the date of the investigational product administration to the time of PD or death from any cause, whichever occurs first
Measured: 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:Overall survival (OS)
Time from the date of the investigational product administration to death due to any cause
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study start8 Aug 2023
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eutilex
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798026
- Sponsor's protocol ID
- EU-CTS103-I-01
- Status last verified
- Mar 2024
- First submitted
- 22 Mar 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-escalation, Single-arm, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of EU103 in an Advanced or Metastatic Solid Tumors Who Have Failed Standard Therapy
- ClinicalTrials.gov ID
- NCT05798026
- Acronym / sponsor ID
- EU-CTS103-I-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- EutilexIndustry (pharma, biotech, devices)
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 1 (dose escalation) of this study will evaluate:
The safety and tolerability of EU103 treatment are evaluated for patients with advanced or metastatic solid tumors who have failed standard therapy to determine the maximum tolerated dose and recommended Phase 2 dose.
And preliminary efficacy (tumor response), The pharmacokinetic characteristics are evaluated, and changes are investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| EU103: Dose Escalation Cohort | Experimental | Drug: EU103Participants with advanced solid tumors will receive EU103 intravenously once every 3 weeks (3 weeks = 1 cycle) with escalating doses starting from 1 milligrams per kilogram (mg/kg) for each cohort and increasing to 3, 6, 12 or 24 mg/kg until disease progression, unacceptable toxicities or death, withdrawal of consent, end of study, or physician's decision, whichever occurs first. |
| EU103: Dose Escalation Cohort 1 | Experimental | Drug: EU1031 mg/kg |
| EU103: Dose Escalation Cohort 2 | Experimental | Drug: EU1033 mg/kg |
| EU103: Dose Escalation Cohort 3 | Experimental | Drug: EU1036 mg/kg |
| EU103: Dose Escalation Cohort 4 | Experimental | Drug: EU10312 mg/kg |
| EU103: Dose Escalation Cohort 5 | Experimental | Drug: EU10324 mg/kg |
| Backfill cohort | Other | Drug: EU103Additional subjects can be registered at doses confirmed to be safety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Adult males or females aged 18 years (or 19 years according to local regulatory requirements) or older at the time of obtaining written consent
- Patients with histologically or cytologically confirmed unresectable advanced or metastatic solid tumors who have failed locally known standard therapies or are unable to apply any more standard therapies.
- Patients with at least 1 measurable or non-measurable lesion per RECIST v1.1
- Patients with an estimated survival of 3 months or longer, as determined by the investigator
- Patients with ECOG PS 0-2
Key exclusion criteria (21 listed)
- Patients who have received prior anticancer therapy, monoclonal antibodies, chemotherapy, live vaccines, or other investigational products, or have a history of treatment with an investigational medical device within 4 weeks prior to the first dose of the investigational product
- Patients who have not recovered (to Grade 1 or better, or the baseline level per NCI-CTCAE v5.0) from the adverse events (excluding alopecia) caused by prior anticancer therapy based on the start date of the first dose of the investigational product
- Patients with a history of radiotherapy within 2 weeks prior to the investigational product administration Note. Subjects must have recovered from all radiation-related toxicities, not require corticosteroid use, and have no history of radiation pneumonitis. A 1-week recovery period is allowed for palliative radiotherapy (not more than 2 weeks of radiotherapy) for diseases other than the central nervous system (CNS) diseases.
- Patients with a history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, or evidence of active pneumonia, or past history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or evidence of clinically active ILD
- Patients with symptomatic ascites or pleural effusion Note. Enrollment is allowed if clinically stable after treatment for the condition (including thoracentesis or paracentesis for therapeutic purposes).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EU103EU103 will be administered via intravenous infusion. | Drug | Backfill cohort, EU103: Dose Escalation Cohort, EU103: Dose Escalation Cohort 1, EU103: Dose Escalation Cohort 2, EU103: Dose Escalation Cohort 3, EU103: Dose Escalation Cohort 4, EU103: Dose Escalation Cohort 5 |
Primary outcome
Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events
Time frame: Baseline up to 30 months
Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Dose Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (Each cycle is of 21 Days)
Number of Participants With Dose Limiting Toxicity (DLT)
Phase 1:Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Time frame: Time Frame: Baseline up to 24 months
Laboratory assessments include hematology, serum chemistry, other blood tests, coagulation, and urine analysis. Number of participants with clinically significant abnormalities will be reported.
Number of participants with clinically significant abnormalities
Time frame: Time Frame: Baseline up to 24 months
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.
Phase 1:Number of Participants With Clinically Significant Abnormalities in Physical Examination
Time frame: Time Frame: Baseline up to 24 months
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.
Phase 1:Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)Physical Examination
Time frame: Time Frame: Baseline up to 24 months
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.
Phase 1:Production of anti-drug antibodies (ADAs)
Time frame: Time Frame: Baseline up to 30 months
The number of subjects, percentage, and Exact 95% confidence interval for subjects who are anti-drug antibody (ADA) positive at each measurement time point compared to before administration of investigational drugs are presented for each dose level.
7 secondary outcomes
Phase 1: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)
Phase 1:Duration of response (DoR)
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)
Phase 1:Disease control rate (DCR)
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)
Phase 1:Time to response (TTR)
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)
Phase 1:Time to progression (TTP)
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)
Phase 1:Progression-free survival (PFS)
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)
Phase 1:Overall survival (OS)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Individual participant dataSharing planned: No
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EU103 in people with Solid Tumor, run by Eutilex at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DongMin Shin (82-2-2071-3318, dmshin@eutilex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events (time frame: Baseline up to 30 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024; AzTrials last refreshed its copy on 3 Nov 2026.