Clinical trial · Interventional
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
NCT01260025CI-TRIAL-00006279completedPhase 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)
1. MTD and DLT of M2ES 2. Pharmacokinetics of M2ES
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endostatin | — | UNRESOLVED | — |
| Pharmacokinetics | — | UNRESOLVED | — |
| Tolerability | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEDylated Recombinant Human Endostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PEDylated Recombinant Human Endostatin
- description
- PEDylated Recombinant Human Endostatin
- interventionNames
- Drug: PEDylated Recombinant Human Endostatin
Primary outcomes (1)
- measure
- Maxinum tolerated dose of M2ES
- timeFrame
- one month
- description
- To assess the adverse events
Secondary outcomes (3)
- measure
- Tumor response rate
- timeFrame
- one month
- description
- To assess the tumor response rate of M2ES in patients with solid, malignant tumours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age between 18 and 65 years;Genders eligible for study: both; * Histologic diagnosis of solid malignancies ; * Performance status of 0 or 1; * Tumor not amenable to standard curative or palliative therapy; * life expectancy beyond 3 months; * Ability to give signed informed consent Exclusion Criteria: * Pregnancy or lactation; * Had a history of brain metastasis or a primary brain tumor; * An active, potentially severe autoimmune disease; * Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance \<60ml/min; WBC count \< 2.0×109/L，hemoglobin \< 90g/L，and platelet count \< 100×109/L; Total bilirubin value \< 2.0 times the upper limit of normal (ULN), ALT level \< 2.0 times ULN, AST \< 2.0 times ULN; * Positive of anti-HIV antibodies; * An active infection; * had received chemotherapy or immunotherapy within the prior 4 weeks before study entry * Participation in a clinical study during the last 28 days * QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG
References
Publications (0)
Data not yet available
No reference posted for this study.