to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage

Study Overview
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Brief Summary
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This is a study to determine the maximum tolerance dose (MTD) and to evaluate the safety of 188Re-BMEDA-liposome in patient with primary solid tumor in advanced or metastatic stage.

Detailed Description
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Rhenium-188 is an ideal radionuclide for therapeutic use due to its maximum beta emission of 2.12MeV, short physical half-life of 16.9 hours, and its 155-keV gamma emission for imaging purposes. 188Re-BMEDA-liposome consists of 2 separate components (Rhenium-188 and liposome) and BMEDA as a linker. This study aims to find the MTD, evaluate the safety, efficacy profiles and investigate the biodistribution, radioactivity and radiation dosimetry of 188Re-BMEDA-liposome on primary solid tumor in metastatic stage patient by a single intravenous injection course.

Official Title
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A Phase I, Open-label, Dose-escalation Study to Determine the Maximum Tolerance Dose (MTD) and to Evaluate the Safety of 188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage.

Conditions
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Tumors

Intervention / Treatment
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* Radiation: 188Re-BMEDA-liposome


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with histologically confirmed diagnosis of primary solid tumor, and with pathologically or radiologically documented metastases Disease that is measurable or evaluable by RECIST 1.1 criteria (for Solid Tumors) Patient with metastatic cancer that are refractory to current standard/available therapies Exclusion Criteria: brain metastases serious concurrent infection or nonmalignant illness that is uncontrolled uncontrolled intercurrent illness Immunocompromised significant traumatic injury within 3 weeks before Day 0 History of hypersensitivity to any component of study drug

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 188Re-BMEDA-liposome<br>Stage I: 188Re-BMEDA-liposomes, 14±1.4 mCi, single dose Stage II: 188Re-BMEDA-liposomes, dose-escalation, single dose Dose Level Dose of 188Re-BMEDA-liposome (mCi/kg) 0.42±0.04 mCi/kg 0.63±0.06 mCi/kg 0.84±0.08 mCi/kg 1.05±0.11 mCi/kg 1.26±0.13 mCi/kg 1.47±0.15 mCi/kg | Radiation: 188Re-BMEDA-liposome<br>* EKG at baseline and in 24hours after administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the MTD | The design will use cohort of 3 patients. If none of the first 3 patients experience DLT, then dose escalation will proceed for the next dose level of patients unless the present dose level is level 6 (1.47±0.15 mCi/kg). | up to 30 days per cohort | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in vital signs and pysical examination | assess the safety issue from the change in vital signs (BP, PR, RR and temperature) and physical examinations | from day 0 to up t0 60 days per cohort | 
| change in lab data | assess the safety issue from the change in lab data including heatology lab data change, Biochemistry laboratory data change and urinalysis data change | from day 0 to up t0 60 days per cohort | 
| Adverse event(s) | assessed by NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) v4.03 | from day 0 to up t0 60 days per cohort | 
| Serious Adverse event(s) | All AE(s) and SAE(s) which occurred within follow-up visit after the single dose administration of study drug should be followed until resolution or the event is considered stable. | from day 0 to up t0 60 days per cohort | 
| Change in EKG | Patient will be examined the EKG by standard 12-lead at screen visit for eligibility. After enrollment, patient will be attached on a 24h-portable EKG monitor to monitoring EKG before and post-administration of Stage I and II low dose and therapeutic infusion dose for 24hrs | in 24hrs |