Clinical trial · Interventional
Study of EC0225 for the Treatment of Refractory or Metastatic Tumors
Protocol EC-0225-01: A Phase 1 Study of EC0225 Administered Weeks 1 and 3 of a 4-Week Cycle
NCT00441870CI-TRIAL-00006433completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1 clinical trial evaluating the safety and tolerability of escalating doses of EC0225 in patients with refractory or metastatic tumors who have exhausted standard therapeutic options.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 99mTC-EC20 (Folic acid-technetium 99m conjugate) | Drug | — | UNRESOLVED |
| EC0225, for Injection (Folic acid desacetylvinblastine hydrazide conjugate) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Dose escalation to the highest dose that can be safely administered to produce acceptable, manageable and reversible toxicity in no more than 0 or 1 of 6 patients
Secondary outcomes (4)
- measure
- Pharmacokinetic and pharmacodynamic parameters
- timeFrame
- Obtained during the first cycle of therapy on Days 1 and 3
- measure
- Anti-tumor activity
- timeFrame
- Initial dose of study therapy to disease progression
- measure
- Uptake of 99mTc-Ec20 in tumors and normal tissues
- timeFrame
- 1-2 hours post-administration of 99mTc-EC20
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Histological or cytological diagnosis of neoplasm * No effective standard therapeutic options * ECOG performance status of 0-2 * ≥ to 4 weeks post therapeutic radiation or chemotherapy(≥ to 6 weeks for nitrosureas) and recovery (to baseline status) from associated acute toxicities. Patients previously treated with non-cytotoxic therapy and who have recovered from or have controlled drug-associated toxicity are allowed to enter the trial after a period consisting of 4 half-lives of the agent. * Negative serum pregnancy test for women of child-bearing potential within one week prior to treatment with investigational agents (99mTc-EC20 and EC0225) * Adequate bone marrow reserve, renal and hepatic function Exclusion Criteria: * Concurrent malignancies * Women who are pregnant or lactating * Evidence of symptomatic brain metastases * Receiving concomitant anticancer therapy (excluding supportive care) * Requires palliative radiotherapy at time of study entry * Unable to tolerate conditions for radionuclide imaging * Administration of another radiopharmaceutical that would interfere with assessment of 99mTc-EC20
References
Publications (0)
Data not yet available
No reference posted for this study.