Clinical trial · Interventional
to evaluate188Re-BMEDA-liposome in Patient With Primary Solid Tumor in Advanced or Metastatic Stage
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.
NCT02271516CI-TRIAL-00046293terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Some concerns arose for the accumulation of radioactivity in liver and spleen.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 188Re-BMEDA-liposome | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 188Re-BMEDA-liposome
- description
- 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) 1. 0.42±0.04 mCi/kg 2. 0.63±0.06 mCi/kg 3. 0.84±0.08 mCi/kg 4. 1.05±0.11 mCi/kg 5. 1.26±0.13 mCi/kg 6. 1.47±0.15 mCi/kg
- interventionNames
- Radiation: 188Re-BMEDA-liposome
Primary outcomes (1)
- measure
- Determine the MTD
- timeFrame
- up to 30 days per cohort
- description
- 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).
Secondary outcomes (5)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.