Clinical trial · Interventional
Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors
NCT01226030CI-TRIAL-00004042unknownPhase 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 study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| M2ES 15mg | Drug | — | UNRESOLVED |
| M2ES 30mg | Drug | — | UNRESOLVED |
| M2ES 60mg | Drug | — | UNRESOLVED |
| M2ES 7.5mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- M2ES 7.5mg
- description
- M2ES 7.5mg
- interventionNames
- Drug: M2ES 7.5mg
- type
- EXPERIMENTAL
- label
- M2ES 15mg
- description
- M2ES 15mg
- interventionNames
- Drug: M2ES 15mg
- type
- EXPERIMENTAL
- label
- M2ES 30mg
- description
- M2ES 30mg
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 to 60 years of age 2. patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy. 3. life expectancy of at least 3 months. 4. ECOGPS ≤ 1 5. Adequate hematologic, renal, and hepatic function was required as determined by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤1.5 upper limit of normal \[ULN\],AST ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min. Exclusion Criteria: 1. Pregnant and latent women, no contraception for women of childbearing age 2. Have taken other treatments 3. Be allergic to endostatin and other ingredient 4. Gastrointestinal Hemorrhage 5. Have Participated any clinical trail during the last 4 week 6. ECG: QTC ≥ 480 ms 7. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.) 8. Cardiovascular and mental disease 9. HIV-1 infected 10. HBV, HBV infected ,Hepatitis B surface antigen positive 11. Patients on therapeutic doses of heparin or antiplatelet agents.
References
Publications (0)
Data not yet available
No reference posted for this study.